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510(k)s Final Decisions Rendered for October 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-OCT-2003 THROUGH 31-OCT-2003 DEVICE: SWISS MASTER LIGHT (EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K032099(TRADITIONAL) ATTN: CYNTHIA J M. NOLTE PHONE NO : 919-859-4207 49 PLAIN ST. SE DECISION MADE: 27-OCT-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; AT 3M COMPANY 510(k) NO: K031012(TRADITIONAL) ATTN: CYNTHIA LAMARUCCIOLA PHONE NO : 651-736-1523 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 16-OCT-03 ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 3M LIQUID BANDAGE, MODEL 120-LB 3M COMPANY 510(k) NO: K031263(TRADITIONAL) ATTN: ANNA E MCRIGHT PHONE NO : 651-733-7948 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 07-OCT-03 ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. 510(k) NO: K032499(SPECIAL) ATTN: JERRY WANG PHONE NO : 408-263-5333 1555 MC CANDLESS DR. SE DECISION MADE: 30-OCT-03 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CAL ABBOTT LABORATORIES 510(k) NO: K032458(ABBREVIATED) ATTN: DENISE FARMER PHONE NO : 847-938-5032 200 ABBOTT PARK RD. SE DECISION MADE: 06-OCT-03 ABBOTT PARK, IL 60064-6187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUSONIC A-SCAN MODEL, 24-4000 ACCUTOME, INC. 510(k) NO: K032956(TRADITIONAL) ATTN: JEFFREY L WRIGHT PHONE NO : 610-889-0200 263 GREAT VALLEY PKWY. SE DECISION MADE: 10-OCT-03 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE3 RADIATION THERAPY PLANNING SYSTEM ADAC LABORATORIES 510(k) NO: K032724(TRADITIONAL) ATTN: RANDY VADER PHONE NO : 608-288-6945 6400 ENTERPRISE LANE,STE.201 SE DECISION MADE: 09-OCT-03 MADISON, WI 53719 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FORTE GAMMA CAMERA SYSTEM ADAC LABORATORIES 510(k) NO: K033254(TRADITIONAL) ATTN: JOY M SACMAR PHONE NO : 408-468-3053 540 ALDER DR. SE DECISION MADE: 22-OCT-03 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADEPT 1064/532/755 LASER ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K032218(TRADITIONAL) ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238 29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 24-OCT-03 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADEPT 1064/532 LASER ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K032220(TRADITIONAL) ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238 29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 24-OCT-03 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADEPT 1064/755 LASER ADEPT MEDICAL CONCEPTS, INC. 510(k) NO: K032221(TRADITIONAL) ATTN: JERRY MCFARLAND PHONE NO : 949-635-9238 29866 AVENIDA DE LAS BANDERAS SE DECISION MADE: 24-OCT-03 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANS AXXESS PERCUTANEOUS LEAD ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K032034(TRADITIONAL) ATTN: KATRYNA WARREN PHONE NO : 972-309-8109 6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 03-OCT-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: PLACER ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K032349(TRADITIONAL) ATTN: KATRYNA WARREN PHONE NO : 972-309-8000 6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 03-OCT-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: MODIFICATION TO RENEW LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K032751(SPECIAL) ATTN: DANIELLE ALARCON PHONE NO : 972-309-8000 6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 06-OCT-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: HEART 2006 AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K032736(SPECIAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SE DECISION MADE: 03-OCT-03 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM ALARA, INC. 510(k) NO: K032210(TRADITIONAL) ATTN: DIANE M KING PHONE NO : 510-723-0110 2545 BARRINGTON CT. SE DECISION MADE: 02-OCT-03 HAYWARD, CA 94545-1134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD. 510(k) NO: K032801(SPECIAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207 49 PLAIN ST. SE DECISION MADE: 17-OCT-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. 510(k) NO: K030279(TRADITIONAL) ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 03-OCT-03 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM ALOKA CO., LTD. 510(k) NO: K033311(TRADITIONAL) ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 29-OCT-03 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM ALSIUS CORP. 510(k) NO: K030421(TRADITIONAL) ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150 15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 23-OCT-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST AMEDICA BIOTECH, INC. 510(k) NO: K031497(TRADITIONAL) ATTN: JEFF CHEN PHONE NO : 510-785-5980 28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 17-OCT-03 HAYWARD, CA 94545 510(k) STATEMENT DEVICE: EASYGLUCO, MODEL IGM0002 AMERICAN HEALTHCARE INC. 510(k) NO: K031501(TRADITIONAL) ATTN: EDWARD LETCO PHONE NO : 917-402-5900 304 PARK AVENUE SOUTH SE DECISION MADE: 16-OCT-03 SUITE 206 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10010 DEVICE: REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEM AMERICAN I.V. PRODUCTS, INC. 510(k) NO: K032789(TRADITIONAL) ATTN: GREGORY FALK PHONE NO : 410-787-1300 7485 SHIPLEY AVE. SE DECISION MADE: 09-OCT-03 HANOVER, MD 21076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSURE FOLEY CATHETER AMSINO INTERNATIONAL, INC. 510(k) NO: K030120(TRADITIONAL) ATTN: CHING CHING SEAH PHONE NO : 909-390-5688 4501 BRICKELL PRIVADO ST. SE DECISION MADE: 29-OCT-03 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: COMBI-SCREEN, MODELS 10SL AND 11SL ANALYTICON BIOTECHNOLOGIES AG 510(k) NO: K023885(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 21-OCT-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL IR 1200 INSULIN PUMP ANIMAS CORP. 510(k) NO: K032257(TRADITIONAL) ATTN: MICHAEL J ANDREWS PHONE NO : 610-644-8990 590 E. LANCASTER AVE. SE DECISION MADE: 16-OCT-03 FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. 510(k) NO: K031523(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 2 CORPORATE CENTER DR. SE DECISION MADE: 01-OCT-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 APPLIED DIABETES RESEARCH, INCORPO510(k) NO: K033099(SPECIAL) ATTN: JIM BARLEY PHONE NO : 949-364-9349 28481 LAFALDA SE DECISION MADE: 16-OCT-03 LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICAL SEPARATOR APPLIED MEDICAL RESOURCES 510(k) NO: K032889(TRADITIONAL) ATTN: CHERYL BLAKE PHONE NO : 949-713-8327 22872 AVENIDA EMPRESA SE DECISION MADE: 02-OCT-03 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO SUTURE CLINCH APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K033024(SPECIAL) ATTN: CHERYL BLAKE PHONE NO : 949-713-8327 22872 AVENIDA EMPRESSA SE DECISION MADE: 24-OCT-03 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBI ARROW INTL., INC. 510(k) NO: K032962(SPECIAL) ATTN: ELIZABETH PRICE PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 29-OCT-03 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SC ARTHREX, INC. 510(k) NO: K032098(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 07-OCT-03 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE ENT PLASMA WANDS ARTHROCARE CORP. 510(k) NO: K033257(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426 680 VAQUEROS AVE. SE DECISION MADE: 30-OCT-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE ARTHROTEK, INC. 510(k) NO: K032072(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 574-372-1761 P.O. BOX 587 SE DECISION MADE: 01-OCT-03 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION MODULAR RADIAL HEAD ASCENSION ORTHOPEDICS, INC. 510(k) NO: K032686(TRADITIONAL) ATTN: PETER STRZEPA PHONE NO : 512-836-5001 8200 CAMERON RD., SUITE C-140 SE DECISION MADE: 22-OCT-03 AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER AVITA CORPORATION 510(k) NO: K031503(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL, SE DECISION MADE: 24-OCT-03 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. 510(k) NO: K032144(TRADITIONAL) ATTN: AMY SMITH PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 01-OCT-03 ALLENTOWN, PA 18103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/M BECTON, DICKINSON AND COMPANY 510(k) NO: K032655(TRADITIONAL) ATTN: KATHRYN B POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 06-OCT-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM BEHAVIORAL TECHNOLOGY, INC. 510(k) NO: K033126(SPECIAL) ATTN: SUSAN E OLSEN PHONE NO : 801-363-9017 24 M ST., #1 SE DECISION MADE: 29-OCT-03 SALT LAKE CITY, UT 84103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BETEC RETRACTABLE SAFETY SYRINGE (5ML) BETEC MEDICAL SCIENCE CO., LTD. 510(k) NO: K031909(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 07-OCT-03 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL S BINAX, INC. 510(k) NO: K032166(TRADITIONAL) ATTN: PAMELA ANGELL PHONE NO : 207-772-3988 217 READ ST. SE DECISION MADE: 21-OCT-03 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFUSION BONE VOID FILLER KIT BIOGENERATION 510(k) NO: K031838(TRADITIONAL) ATTN: BERNARD F GRISONI PHONE NO : 901-380-9411 9160 HIGHWAY 64 SE DECISION MADE: 30-OCT-03 SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA LAKELAND, TN 38002 DEVICE: THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K032351(TRADITIONAL) ATTN: WINSTON D GREER PHONE NO : 205-967-7880 ONE PERIMETER PARK SOUTH SE DECISION MADE: 21-OCT-03 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPUR BIOLAB EQUIPMENT CANADA LTD. 510(k) NO: K030348(TRADITIONAL) ATTN: JERRY PONIKVAR PHONE NO : 905 882 2068 128 GRANDVIEW AVE. SE DECISION MADE: 21-OCT-03 THORNHILL, ONTARIO, CANADA L3T 1H6510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASERSMILE BIOLASE TECHNOLOGY, INC. 510(k) NO: K030539(TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200 981 CALLE AMANECER SE DECISION MADE: 10-OCT-03 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUID SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTR510(k) NO: K030394(TRADITIONAL) ATTN: SUSAN B FENTRESS PHONE NO : 901-680-7319 6075 POPLAR AVE. SE DECISION MADE: 27-OCT-03 SUITE 500 510(k) STATEMENT MEMPHIS, TN 38119 DEVICE: VITEK GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC. 510(k) NO: K032711(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 31-OCT-03 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN BIOMERIEUX, INC. 510(k) NO: K032738(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM DR. SE DECISION MADE: 31-OCT-03 HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE LINEZOLID BIOMERIEUX, INC. 510(k) NO: K032766(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 31-OCT-03 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOPKIN WOUND DRESSING BIOMET MERCK GMBH 510(k) NO: K031684(TRADITIONAL) ATTN: THOMAS KIEWITT PHONE NO : 49 615 1722004 ATLES WIDALMI 12 SE DECISION MADE: 30-OCT-03 RIED BEI KERZERS, SWITZERLAND 3216510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS BIONOSTICS, INC. 510(k) NO: K032819(TRADITIONAL) ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070 7 JACKSON RD. SE DECISION MADE: 20-OCT-03 DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHERON PTA CATHETER BIOTRONIK, INC. 510(k) NO: K033217(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 31-OCT-03 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS BLACKSTONE MEDICAL, INC. 510(k) NO: K032700(SPECIAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513 90 BROOKSDALE DR. SE DECISION MADE: 09-OCT-03 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAXCEL PLUS CHRONIC DIALYSIS CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K032712(SPECIAL) ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 02-OCT-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K032930(SPECIAL) ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 23-OCT-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. 510(k) NO: K033010(TRADITIONAL) ATTN: CHRIS MANDER PHONE NO : 011 649 9788855 25 CARBINE ROAD MT. WELLINGTON SE DECISION MADE: 10-OCT-03 PO BOX 51-078, PARURANGA 510(k) SUMMARY AVAILABLE FROM FDA AUCKLAND, NEW ZEALAND THIRD PARTY REVIEW DEVICE: BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN GMBH 510(k) NO: K031928(ABBREVIATED) ATTN: FRED SCHLADOR PHONE NO : 760-929-2170 6183 PASEO DEL MORTE SE DECISION MADE: 24-OCT-03 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 C.R. BARD, INC. 510(k) NO: K030627(TRADITIONAL) ATTN: DEBORAH HERRINGTON PHONE NO : 978-323-2216 55 TECHNOLOGY DR. SE DECISION MADE: 23-OCT-03 LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-235 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K032918(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DR. SE DECISION MADE: 06-OCT-03 PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-250 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K032919(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DR. SE DECISION MADE: 15-OCT-03 PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS CANDELA CORP. 510(k) NO: K033172(TRADITIONAL) ATTN: LORRAINE CALZETTA-PATROVIC PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 30-OCT-03 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING CARDINAL HEALTH 510(k) NO: K031301(TRADITIONAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 15-OCT-03 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE CEMENT RADIO-OPACIFIER CARDINAL HEALTH 510(k) NO: K032388(TRADITIONAL) ATTN: SHARON NICHOLS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 31-OCT-03 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K033037(TRADITIONAL) ATTN: JANET WAINMAN PHONE NO : 250 744 1822 3060 CEDAR HILL ROAD SE DECISION MADE: 31-OCT-03 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA VICTORIA, B.C., CANADA V8T 3J5 DEVICE: CAREMATIX WELLNESS SYSTEM CAREMATIX INC. 510(k) NO: K031840(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 10-OCT-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPSILON DURASUL CONSTRAINED ACETABULAR LINER CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K030923(TRADITIONAL) ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324 9900 SPECTRUM DR. SE DECISION MADE: 03-OCT-03 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K032348(TRADITIONAL) ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324 9900 SPECTRUM DR. SE DECISION MADE: 24-OCT-03 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D INVIVO BY CSIST CHUNG-SHAN INSTITUTE OF SCIENCE AN510(k) NO: K031567(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 02-OCT-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME CIBA VISION CORP. 510(k) NO: K032978(SPECIAL) ATTN: PENNY NORTHCUTT PHONE NO : 678-415-3214 11460 JOHNS CREEK PKWY. SE DECISION MADE: 20-OCT-03 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN C CLINIQA CORPORATION 510(k) NO: K032074(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432-B SOUTH MISSION RD. SE DECISION MADE: 21-OCT-03 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS A CLINIQA CORPORATION 510(k) NO: K033162(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432 SOUTH MISSION RD. SE DECISION MADE: 10-OCT-03 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: CLUED UP MULTIPURPOSE SOLUTION- NO RUB CLUED UP LIMITED 510(k) NO: K030910(TRADITIONAL) ATTN: JENNY KOKSHUN PHONE NO : 442 083 224204 135 HIGH ST. SE DECISION MADE: 10-OCT-03 EGHAM, SURREY, UNITED KINGDOM TW20510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE COAPT SYSTEMS, INC. 510(k) NO: K032698(TRADITIONAL) ATTN: LORI DONDIEGO PHONE NO : 650-461-7600 1820 EMBARCADERO RD. SE DECISION MADE: 23-OCT-03 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOTINE FOREHEAD DEVICE COAPT SYSTEMS, INC. 510(k) NO: K032770(SPECIAL) ATTN: LORI DONDIEGO PHONE NO : 650-461-7600 1820 EMBARCADERO RD. SE DECISION MADE: 08-OCT-03 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-BEAM COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K032100(TRADITIONAL) ATTN: KATHRYN STINSON PHONE NO : 314-993-0003 1145 CORPORATE LAKE DR. SE DECISION MADE: 02-OCT-03 ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOM COOK VASCULAR, INC. 510(k) NO: K032223(TRADITIONAL) ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621 RT. 66, RIVER RD. SE DECISION MADE: 15-OCT-03 P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA LEECHBURG, PA 15656-0529 DEVICE: ENK FIBEROPTIC ATOMIZER SET COOK, INC. 510(k) NO: K031966(TRADITIONAL) ATTN: JENNIFER J BOSLEY PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 16-OCT-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET COOK, INC. 510(k) NO: K032426(TRADITIONAL) ATTN: JENNIFER J BOSLEY PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 31-OCT-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: PTA BALLOON CATHETER COOK, INC. 510(k) NO: K032931(SPECIAL) ATTN: KAREN BRADBURN PHONE NO : 800-346-2686 750 DANIELS WAY SE DECISION MADE: 22-OCT-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX CORDIS EUROPA N.V. 510(k) NO: K032737(SPECIAL) ATTN: KAREN WILK PHONE NO : 908-412-7257 7 POWDER HORN DR. SE DECISION MADE: 02-OCT-03 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL CORGENIX, INC. 510(k) NO: K032868(SPECIAL) ATTN: NANCI DEXTER PHONE NO : 303-457-4345 12061 TEJON ST. SE DECISION MADE: 14-OCT-03 WESTMINSTER, CO 80234 510(k) STATEMENT DEVICE: AUTOALIGN CORTECHS LABS, INC. 510(k) NO: K032186(ABBREVIATED) ATTN: ALLAN GREEN PHONE NO : 671-241-9588 6 13TH ST. SE DECISION MADE: 14-OCT-03 CHARLESTOWN, MA 02129-2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 CTF SYSTEMS (2001), INC. 510(k) NO: K030737(SPECIAL) ATTN: DARYL WISDAHL PHONE NO : 604 941 8561 15-1750 MCLEAN AVE. SE DECISION MADE: 10-OCT-03 PORT COQUITLAM, B.C., CANADA V3C 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE SMART FILE ND:YAG LASERS CYNOSURE, INC. 510(k) NO: K031125(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 09-OCT-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE SMART 2940D ER:YAG LASER CYNOSURE, INC. 510(k) NO: K031389(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 01-OCT-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER CYNOSURE, INC. 510(k) NO: K031440(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 01-OCT-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE PHOTOGENICA VL CYNOSURE, INC. 510(k) NO: K032565(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 22-OCT-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE MET DADE BEHRING, INC. 510(k) NO: K032564(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 31-OCT-03 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MOD DADE BEHRING, INC. 510(k) NO: K032573(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 31-OCT-03 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: DIMENSION DRUG CALIBRATOR II, MODEL DC49C DADE BEHRING, INC. 510(k) NO: K032574(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 06-OCT-03 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDG DADE BEHRING, INC. 510(k) NO: K032798(TRADITIONAL) ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 30-OCT-03 BLDG. 500 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS DANMAR PRODUCTS, INC. 510(k) NO: K013452(TRADITIONAL) ATTN: KAREN A LINDNER PHONE NO : 734-761-1990 221 JACKSON INDUSTRIAL DR. SE DECISION MADE: 31-OCT-03 ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWPOINT TELEMETRY SYSTEM DATASCOPE CORP. 510(k) NO: K031760(ABBREVIATED) ATTN: SUSAN E MANDY PHONE NO : 201-995-8025 800 MACARTHUR BLVD. SE DECISION MADE: 10-OCT-03 MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 S DATEX-OHMEDA 510(k) NO: K033078(SPECIAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 29-OCT-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS DATEX-OHMEDA, INC. 510(k) NO: K023366(TRADITIONAL) ATTN: MICHAEL A CHILBERT PHONE NO : 608-221-1551 P.O. BOX 7550 SE DECISION MADE: 07-OCT-03 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL AMBULATORY ECG (HOLTER) RECORDER DATRIX 510(k) NO: K031074(TRADITIONAL) ATTN: LAUREN M LUHMANN PHONE NO : 760-480-8874 340 STATE PLACE SE DECISION MADE: 15-OCT-03 ESCONDIDO, CA 92029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBB-05 HEMODIALYSIS DELIVERY SYSTEM DAVITA CLINICAL RESEARCH (TRRI) 510(k) NO: K023509(TRADITIONAL) ATTN: TRACY L GRAY PHONE NO : 763-287-3830 4050 OLSON MEMORIAL HWY SE DECISION MADE: 30-OCT-03 MINNEAPOLIS, MN 55422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT DENTAURUM 510(k) NO: K032195(TRADITIONAL) ATTN: JAN A DOORSCHODT PHONE NO : 215-968-2858 10 PHEASANT RUN SE DECISION MADE: 07-OCT-03 NEWTOWN, PA 18940 510(k) STATEMENT DEVICE: APPOLLO 3 ALLOY DENTSPLY INTERNATIONAL 510(k) NO: K032320(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 01-OCT-03 P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17405-0872 DEVICE: CLS-2000 UNIT DENTSPLY INTL. 510(k) NO: K024133(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 01-OCT-03 YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 DENTSPLY INTL. 510(k) NO: K032904(SPECIAL) ATTN: JOHN R MILLER PHONE NO : 847-640-4924 901 W. OAKTON ST. SE DECISION MADE: 14-OCT-03 DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE NANCY NAIL DEPUY ORTHOPAEDICS, INC. 510(k) NO: K032687(TRADITIONAL) ATTN: RHONDA MYER PHONE NO : 574-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 06-OCT-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) DEROYAL 510(k) NO: K031408(TRADITIONAL) ATTN: AUDREY DANIELS PHONE NO : 865-362-2091 200 DEBUSK LN. SE DECISION MADE: 15-OCT-03 POWELL, TN 37849 510(k) STATEMENT DEVICE: IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTA DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K032881(SPECIAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 10-OCT-03 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 2100 PULSE OXIMETER DOLPHIN MEDICAL INC. 510(k) NO: K031465(SPECIAL) ATTN: JON WERNER PHONE NO : 813-818-7488 13801 MCCORMICK DR. SE DECISION MADE: 10-OCT-03 TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 DOLPHIN MEDICAL INC. 510(k) NO: K032947(SPECIAL) ATTN: BILL CURNAN PHONE NO : 720-348-0389 9433 S. MORNING GLORY LN. SE DECISION MADE: 17-OCT-03 LITTLETON, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033305(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 31-OCT-03 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM DUCKWORTH & KENT, LTD. 510(k) NO: K024072(TRADITIONAL) ATTN: MARTIN LOCK PHONE NO : 011 441 462893254 TERENCE HOUSE, 7 MARQUIS SE DECISION MADE: 06-OCT-03 BUSINESS CENTRE ROYSTON RD. 510(k) STATEMENT BALDOCK, HERTS, UNITED KINGDOM SG7 6XL DEVICE: DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED DYNATRONICS CORP. 510(k) NO: K031329(TRADITIONAL) ATTN: RON HATCH PHONE NO : 801-568-7000 7030 PARK CENTRE DR. SE DECISION MADE: 22-OCT-03 SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI ACUMEN SURGICAL NAVIGATION SYSTEM EBI, L.P. 510(k) NO: K031732(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 15-OCT-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS PERIPHERAL DILATATION CATHETER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K032587(TRADITIONAL) ATTN: KEVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 02-OCT-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-STRIP EEMSO, INC. 510(k) NO: K031769(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7561 1900 K STREET, NW SE DECISION MADE: 14-OCT-03 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. 510(k) NO: K033214(SPECIAL) ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 14-OCT-03 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: ELEKTA SYNERGY SYSTEM ELEKTA ONCOLOGY SYSTEMS, LTD. 510(k) NO: K032996(SPECIAL) ATTN: PETER STEGAGNO PHONE NO : 770-300-9725 4775 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 23-OCT-03 BLDG 300, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES ELITE INTERNATIONAL, INC. 510(k) NO: K032616(TRADITIONAL) ATTN: BOBBY LING PHONE NO : 800-788-9486 18709 GREENBAY DR. SE DECISION MADE: 02-OCT-03 ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT DEVICE: EM PROBE, EM PAD EM PROBE INC. 510(k) NO: K024361(TRADITIONAL) ATTN: GLEN A GORDON PHONE NO : 360-797-7900 1501 OLD GARDINER RD. SE DECISION MADE: 09-OCT-03 SEQUIM, WA 98382 510(k) STATEMENT DEVICE: ENDOHELIX ENDARTERECTOMY DEVICE ENDARX, INC. 510(k) NO: K032105(TRADITIONAL) ATTN: SCOTT ADAMS PHONE NO : 650-926-9335 3270 ALPINE ROAD SE DECISION MADE: 30-OCT-03 PORTOLA VALLEY, CA 94028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE SYSTEM ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K033211(SPECIAL) ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 30-OCT-03 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWMATE ULTRASOUND IMAGING SYSTEM EP MEDSYSTEMS 510(k) NO: K031066(TRADITIONAL) ATTN: JOHN J TALARICO PHONE NO : 856-753-8533 COOPER RUN EXECUTIVE PARK SE DECISION MADE: 17-OCT-03 575 ROUTE 73 N. BLDG. D 510(k) STATEMENT WEST BERLIN, NJ 08091 DEVICE: ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVE ESSEX MEDICAL SYSTEMS PLUS 510(k) NO: K024023(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 01-OCT-03 SUITE 200 510(k) STATEMENT GREAT NECK, NY 11021 DEVICE: REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH ESTECH, INC. 510(k) NO: K032632(ABBREVIATED) ATTN: ARTHUR BERTOLERO PHONE NO : 925-648-3500 4135 BLACKHAWK PLAZA CIRCLE SE DECISION MADE: 22-OCT-03 #150 510(k) SUMMARY AVAILABLE FROM FDA DANVILLE, CA 94506 DEVICE: CAP BONE SUBSTITUTE MATERIAL ETEX CORP. 510(k) NO: K032307(TRADITIONAL) ATTN: KRISTINE CANAVAN PHONE NO : 617-577-7270 UNIVERSITY PARK AT MIT SE DECISION MADE: 24-OCT-03 38 SIDNEY STREET 510(k) SUMMARY AVAILABLE FROM FDA CAMBRIDGE, MA 02139 DEVICE: MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYS ETHICON ENDO-SURGERY, INC. 510(k) NO: K030472(TRADITIONAL) ATTN: MICHAEL J CRADER PHONE NO : 513-337-8581 4545 CREEK RD. SE DECISION MADE: 09-OCT-03 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH D ETHICON ENDO-SURGERY, INC. 510(k) NO: K032676(TRADITIONAL) ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146 4545 CREEK RD. SE DECISION MADE: 30-OCT-03 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNT ETHICON, INC. 510(k) NO: K032420(TRADITIONAL) ATTN: REY LIBROJO PHONE NO : 908-218-3198 ROUTE 22 WEST SE DECISION MADE: 22-OCT-03 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUF-COVER (TM) ETHOX CORP. 510(k) NO: K031195(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 10-OCT-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL A EUROSURGICAL S.A. 510(k) NO: K031471(TRADITIONAL) ATTN: KAREN E WARDEN PHONE NO : 304-598-0525 7000 HAMPTON CENTER SE DECISION MADE: 10-OCT-03 SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA MORGANTOWN, WV 26505 DEVICE: PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM EV3 INC 510(k) NO: K032580(SPECIAL) ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391 4600 NATHAN LN. NORTH SE DECISION MADE: 22-OCT-03 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K033140(SPECIAL) ATTN: JAY MANSOR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 29-OCT-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT MILLENNIUM III FASSTECH 510(k) NO: K023209(TRADITIONAL) ATTN: LEE BRODY PHONE NO : 978-663-2800 76 TREBLE COVE RD. SE DECISION MADE: 10-OCT-03 BUILDING #2 510(k) SUMMARY AVAILABLE FROM FDA NORTH BILLERICA, MA 01862 DEVICE: FERRIS POLYMEM SILVER WOUND DRESSING FERRIS MFG. CORP. 510(k) NO: K031307(TRADITIONAL) ATTN: THEODORE THORSEN PHONE NO : 630-734-7830 16W300 83RD ST. SE DECISION MADE: 22-OCT-03 BURR RIDGE, IL 60527-5848 510(k) STATEMENT DEVICE: FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 FMS, FINAPRES MEDICAL SYSTEMS BV 510(k) NO: K023723(TRADITIONAL) ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312 1205 DE LA VINA ST. SE DECISION MADE: 23-OCT-03 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M FOCUS TECHNOLOGIES, INC. 510(k) NO: K031952(TRADITIONAL) ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900 10703 PROGRESS WAY SE DECISION MADE: 22-OCT-03 CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEST NILE VIRUS ELISA IGG, MODEL EL0300G FOCUS TECHNOLOGIES, INC. 510(k) NO: K031953(TRADITIONAL) ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900 10703 PROGRESS WAY SE DECISION MADE: 22-OCT-03 CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIVE TG ABUTMENTS FRIADENT GMBH 510(k) NO: K032302(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 02-OCT-03 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE FRIANDENT GMBH 510(k) NO: K032750(SPECIAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 02-OCT-03 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MO FUKUDA DENSHI USA, INC. 510(k) NO: K032290(SPECIAL) ATTN: LARRY D WALKER PHONE NO : 425-881-7737 17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 10-OCT-03 REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUKUDA DENSHI MODEL FF SONIC UF-750XT FUKUDA DENSHI USA, INC. 510(k) NO: K033209(TRADITIONAL) ATTN: LARRY D WALKER PHONE NO : 800-365-6668 17725 NE 65TH STREET SE DECISION MADE: 31-OCT-03 BUILDING C 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052 DEVICE: FIT CHECKER II GC AMERICA, INC. 510(k) NO: K032289(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 20-OCT-03 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X GE MED. SYSTEMS ULTRASOUND & PRIM.510(k) NO: K032656(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 4855 WEST ELECTRIC AVE. SE DECISION MADE: 30-OCT-03 WEST MILWAUKEE, WI 53219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-WAVE ALTERNANS (TWA) ALGORITHM OPTION GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032513(TRADITIONAL) ATTN: DAVID WAHLIG PHONE NO : 262-293-1705 8200 WEST TOWER AVE. SE DECISION MADE: 30-OCT-03 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032577(TRADITIONAL) ATTN: LISA L MICHELS PHONE NO : 262-293-1609 8200 WEST TOWER AVE. SE DECISION MADE: 10-OCT-03 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT GE MEDICAL SYSTEMS, INC. 510(k) NO: K033244(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 16-OCT-03 MAIL STOP W-400 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS, LLC 510(k) NO: K032795(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 08-OCT-03 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE 4D OPTION GE MEDICAL SYSTEMS, LLC 510(k) NO: K032915(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N GRANDVIEW BLVD. SE DECISION MADE: 30-OCT-03 W-400 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: GE LOGIQ BOOK GENERAL ELECTRIC CO. 510(k) NO: K032477(TRADITIONAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 22-OCT-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM GENERAL ELECTRIC CO. 510(k) NO: K032620(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 10-OCT-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 5 PRO OR EXPERT GENERAL ELECTRIC CO. 510(k) NO: K032974(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 4855 WESTELECTRIC AVENUE SE DECISION MADE: 21-OCT-03 PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53219 DEVICE: GE MARLIN ULTRASOUND GENERAL ELECTRIC CO. 510(k) NO: K033139(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 23-OCT-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE 0.2T SIGNA PROFILE/I MR SYSTEM GENERAL ELECTRIC CO. 510(k) NO: K033168(SPECIAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 10-OCT-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERTELL FEMALE FERTILITY TEST GENOSIS, INC. 510(k) NO: K032002(TRADITIONAL) ATTN: SHARON A SEGAL PHONE NO : 202-739-5427 1111 PENNSYLVANIA AVE,NW SE DECISION MADE: 30-OCT-03 WASHINGTON,, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSIGN STEAM-24 BIOLOGICAL INDICATOR GETINGE USA, INC 510(k) NO: K032723(SPECIAL) ATTN: KARLA BYRNE PHONE NO : 585-272-5007 1777 EAST HENRIETTA RD. SE DECISION MADE: 01-OCT-03 ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. 510(k) NO: K032405(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 4 9097784 13 HAYETZIRA STREET SE DECISION MADE: 29-OCT-03 NEW INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: GLOBAL PRESS-FIT STEM GLOBAL MEDICAL CO. 510(k) NO: K032385(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 30-OCT-03 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER GONOTEC GESELLSCHAFT FUER MESS-UND510(k) NO: K032608(ABBREVIATED) ATTN: THOMAS BOCK PHONE NO : 011 490 3091208594 SCHOENHAUSER STRASSE 73C SE DECISION MADE: 21-OCT-03 BERLIN, GERMANY 13158 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JABES ELECTRONIC STETHOSCOPE GS TECHNOLOGY CO., LTD. 510(k) NO: K031446(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 31-OCT-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORPORATION 510(k) NO: K032530(SPECIAL) ATTN: MICHELLE GROSSMAN PHONE NO : 650-470-6372 1525 O'BRIEN DR. SE DECISION MADE: 23-OCT-03 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPHAEL HAMILTON MEDICAL AG 510(k) NO: K022679(TRADITIONAL) ATTN: DAVID THOMPSON PHONE NO : 775-858-3200 P.O. BOX 30008 (89520) SE DECISION MADE: 22-OCT-03 4990 ENERGY WAY 510(k) SUMMARY AVAILABLE FROM FDA RENO, NV 89502 DEVICE: DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. 510(k) NO: K032705(SPECIAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 8905 SW 87TH AVENUE SE DECISION MADE: 01-OCT-03 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33176 DEVICE: HANDIVIPP HANDINOR USA, INC. 510(k) NO: K033125(TRADITIONAL) ATTN: BARBARA CHIPONIS PHONE NO : 763-404-9396 17610 26TH AVE. NORTH SE DECISION MADE: 30-OCT-03 PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) HARRY J. BOSWORTH CO. 510(k) NO: K031439(TRADITIONAL) ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 02-OCT-03 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: HL888BF HEALTH & LIFE CO., LTD. 510(k) NO: K032695(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 02-OCT-03 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: HL888BM HEALTH & LIFE CO., LTD. 510(k) NO: K032837(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-OCT-03 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: HL888BA HEALTH & LIFE CO., LTD. 510(k) NO: K032839(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-OCT-03 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: HL888 AF HEALTH & LIFE CO., LTD. 510(k) NO: K032913(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 02-OCT-03 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: MODIFICATION TO HL168 HEALTH & LIFE CO., LTD. 510(k) NO: K033043(SPECIAL) ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 10-OCT-03 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 HEALTHONICS, INC. 510(k) NO: K030998(TRADITIONAL) ATTN: JAMES W KRONBERG PHONE NO : 803-652-2354 903 MAIN ST. SOUTH SE DECISION MADE: 10-OCT-03 NEW ELLENTON, SC 29809 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 HEMEDEX INCORPORATED 510(k) NO: K032337(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY TRAIL SE DECISION MADE: 21-OCT-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT S HILL-ROM MANUFACTURING, INC. 510(k) NO: K032772(SPECIAL) ATTN: CINDY L CROSBY PHONE NO : 919-854-3217 1225 CRESCENT GREEN SE DECISION MADE: 08-OCT-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA CARY, NC 27511 DEVICE: HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K033248(TRADITIONAL) ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 20-OCT-03 TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM HMD BIOMEDICAL, INC. 510(k) NO: K032985(SPECIAL) ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770 3505 SUNSET AVE. SE DECISION MADE: 21-OCT-03 OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLOGIC DR IMAGEPRO HOLOGIC, INC. 510(k) NO: K032546(TRADITIONAL) ATTN: DANIEL F PHELAN PHONE NO : 781-999-7300 35 CROSBY DR. SE DECISION MADE: 16-OCT-03 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M S HOME CARE TECHNOLOGY CO., LTD. 510(k) NO: K023000(TRADITIONAL) ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918 2064 TAMARIN DR. SE DECISION MADE: 29-OCT-03 COLUMBUS, OH 43235 510(k) STATEMENT DEVICE: ACCOLADE-J HIP STEM SERIES HOWMEDICA OSTEONICS CORP. 510(k) NO: K032300(TRADITIONAL) ATTN: LORRAINE MONTEMURRO PHONE NO : 201-831-5892 59 ROUTE 17 SE DECISION MADE: 09-OCT-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 NAILING SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K032523(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 59 ROUTE 17 SE DECISION MADE: 22-OCT-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL CO HOWMEDICA OSTEONICS CORP. 510(k) NO: K032581(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SE DECISION MADE: 09-OCT-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K032898(SPECIAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 59 ROUTE 17 SOUTH SE DECISION MADE: 09-OCT-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKER I-STAT CORPORATION 510(k) NO: K031873(TRADITIONAL) ATTN: GREGORY W SHIPP PHONE NO : 609-443-9300 104 WINDSOR CENTER DR. SE DECISION MADE: 07-OCT-03 EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOENCODER ICARDIOGRAM, INCORPORATED 510(k) NO: K032324(TRADITIONAL) ATTN: JAMES LOEHR PHONE NO : 919-534-2150 100 EAST SIX FORKS ROAD, SE DECISION MADE: 02-OCT-03 SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA RALIEGH, NC 27609 DEVICE: CENTRA VIEW DEVICE LINK SYSTEM ICU DATASYSTEMS, INC. 510(k) NO: K033283(TRADITIONAL) ATTN: SAMUEL W COONS PHONE NO : 352-692-5585 2153 SE HAWTHORNE ROAD SE DECISION MADE: 27-OCT-03 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA GAINESVILLE, FL 32641 THIRD PARTY REVIEW DEVICE: THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 IMPLEX CORP. 510(k) NO: K032344(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 02-OCT-03 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT IMPLEX CORP. 510(k) NO: K032527(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 31-OCT-03 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION CPS BABY 1.5 BIOABSORBABLE SYSTEM INION LTD. 510(k) NO: K033194(SPECIAL) ATTN: HANNA MARTTILA PHONE NO : 358 323 06600 LAAKARINKATU 2 SE DECISION MADE: 30-OCT-03 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSF400 AND CSF600 INMED LTDA. 510(k) NO: K030081(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 06-OCT-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. 510(k) NO: K032140(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 13TH ST. N.W. SE DECISION MADE: 02-OCT-03 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 INNOVATECH SURGICAL INC. 510(k) NO: K032703(TRADITIONAL) ATTN: MICHAEL J MCGOWAN PHONE NO : 800-240-3123 1000 ATLANTIC AVENUE SE DECISION MADE: 24-OCT-03 SUITE 514 510(k) SUMMARY AVAILABLE FROM FDA CAMDEN, NJ 08104 DEVICE: INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 INNOVATECH SURGICAL INC. 510(k) NO: K032704(TRADITIONAL) ATTN: MICHAEL J MCGOWAN PHONE NO : 800-240-3123 1000 ATLANTIC AVENUE SE DECISION MADE: 24-OCT-03 SUITE 514 510(k) SUMMARY AVAILABLE FROM FDA CAMDEN, NJ 08104 DEVICE: AUDICOR UPGRADE SYSTEM INOVISE MEDICAL, INC. 510(k) NO: K032145(TRADITIONAL) ATTN: STEVE HESLER PHONE NO : 503-554-4291 1025 INDUSTRIAL PKWY. SE DECISION MADE: 31-OCT-03 SUITE C 510(k) SUMMARY AVAILABLE FROM FDA NEWBERG, OR 97132 DEVICE: QUANTEX D-DIMER INSTRUMENTATION LABORATORY CO. 510(k) NO: K032419(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 24-OCT-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTERNAL DRAINAGE SET INTEGRA NEUROSCIENCES IMPLANTS S.A510(k) NO: K032817(SPECIAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 06-OCT-03 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELEPACS INTELERAD MEDICAL SYSTEMS INC. 510(k) NO: K032533(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 16-OCT-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTER-OS LIMB LENGTHENER INTER-OS TECHNOLOGIES 510(k) NO: K031875(TRADITIONAL) ATTN: RANDOLPH C ROBINSON PHONE NO : 303-708-8390 7430 E, PARK MEADOWS DRIVE SE DECISION MADE: 22-OCT-03 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA LONE TREE, CO 80124 DEVICE: RATIONAL IMAGING PACS INTUITIVE IMAGING INFORMATICS, LLC510(k) NO: K031473(TRADITIONAL) ATTN: DONALD MUNDT PHONE NO : 818-347-8919 30 HACKAMORE LN., SUITE 4 SE DECISION MADE: 30-OCT-03 BELL CANYON, CA 91307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: US-100 PORTABLE ULTRASOUND THERAPY UNIT ITO CO., LTD. 510(k) NO: K032793(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013 2305 GOLD MINE RD. SE DECISION MADE: 09-OCT-03 BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVASENS IVOCLAR VIVADENT, INC. 510(k) NO: K030922(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260 175 PINEVIEW DR. SE DECISION MADE: 17-OCT-03 AMHERST, NY 14228 510(k) STATEMENT DEVICE: VISTAKON (GALYFILCON A) SOFT CONTACT LENS JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K032340(TRADITIONAL) ATTN: JACQUELINE ZIMOVAN PHONE NO : 904-443-1402 7500 CENTURION PARKWAY, SE DECISION MADE: 16-OCT-03 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE JS VASCULAR, INC. 510(k) NO: K032411(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 925-254-5228 8 SNOWBERRY COURT SE DECISION MADE: 07-OCT-03 ORINDA, CA 94563 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAVO EVEREST ZH-BLANK KAVO AMERICA CORPORATION 510(k) NO: K033221(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 28-OCT-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE KIMBERLY-CLARK CORP. 510(k) NO: K031750(TRADITIONAL) ATTN: RICHARD V WOLFE PHONE NO : 770-587-8208 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 24-OCT-03 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISO-ELASTIC CERCLAGE SYSTEM KINAMED, INC. 510(k) NO: K030256(TRADITIONAL) ATTN: VINEET SARIN PHONE NO : 805-384-2748 820 FLYNN RD. SE DECISION MADE: 21-OCT-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS KINETIC CONCEPTS, INC. 510(k) NO: K032310(TRADITIONAL) ATTN: JUDITH HARBOUR PHONE NO : 210-255-4468 P.O. BOX 659508 SE DECISION MADE: 10-OCT-03 SAN ANTONIO, TX 78216-9508 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES KINGSWELL INTERNATIONAL INC. 510(k) NO: K032630(TRADITIONAL) ATTN: D.C. CHANG PHONE NO : 909-465-5769 264 CARBONIA AVE. SE DECISION MADE: 03-OCT-03 WALNUT, CA 91789 510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES KINGSWELL INTERNATIONAL INC. 510(k) NO: K032668(TRADITIONAL) ATTN: D.C. CHANG PHONE NO : 909-465-5769 264 CARBONIA AVE. SE DECISION MADE: 07-OCT-03 WALNUT, CA 91789 510(k) STATEMENT DEVICE: KLS-MARTIN STERNAL PLATING SYSTEM KLS-MARTIN L.P. 510(k) NO: K032413(TRADITIONAL) ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 10-OCT-03 SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II KLS-MARTIN L.P. 510(k) NO: K032442(TRADITIONAL) ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 29-OCT-03 SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KONDON (TIANJIN) ELECTRONIC & ELEC510(k) NO: K030358(TRADITIONAL) ATTN: LIU YI PHONE NO : 86 22 27470070 NO. 31 CHANGJIANG ROAD SE DECISION MADE: 31-OCT-03 NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA TIANJIN, CHINA 300193 DEVICE: LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX LALAN GLOVES (PVT) LTD. 510(k) NO: K031386(TRADITIONAL) ATTN: UPUL GUNASINGHE PHONE NO : 009 414 65802 BLOCK B, BEPZ SE DECISION MADE: 06-OCT-03 BIYAGAMA, SRI LANKA 510(k) STATEMENT DEVICE: AQUABOSS ECORO DIA 50 LAUER LTD., HONG KONG 510(k) NO: K032004(TRADITIONAL) ATTN: STEPHAN KRIETEMEYER PHONE NO : 497 621 927015 SPEICHERMATT 9 SE DECISION MADE: 02-OCT-03 WITTLINGEN, GERMANY 79599 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (50 LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K031797(TRADITIONAL) ATTN: CHENG-I LIN PHONE NO : 408-732-3856 687 NORTH PASTORIA AVE. SE DECISION MADE: 10-OCT-03 SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K032461(TRADITIONAL) ATTN: CHENG I LIN PHONE NO : 408-732-3856 687 NORTH PASTORIA AVE. SE DECISION MADE: 03-OCT-03 SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YE LONG FIRST (XIAMEN) PLASTICS CO., 510(k) NO: K032323(TRADITIONAL) ATTN: CHIEN LIN PHONE NO : 773-327-2054 2631 N. MAGNOLIA STREET SE DECISION MADE: 07-OCT-03 CHICAGO, IL 60614 510(k) STATEMENT DEVICE: NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES LUMENIS, INC. 510(k) NO: K032357(TRADITIONAL) ATTN: KAREN BAKER PHONE NO : 408-764-3603 2400 CONDENSA ST. SE DECISION MADE: 09-OCT-03 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDICARE MODEL MT-301F & MT-301C LUMISCOPE CO., INC. 510(k) NO: K032714(TRADITIONAL) ATTN: MARIO MANZANO PHONE NO : 732-254-3800 122 TICES LN. SE DECISION MADE: 22-OCT-03 EAST BRUNSWICK, NJ 08816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY E MAHE INTL., INC. 510(k) NO: K030857(TRADITIONAL) ATTN: PAUL CART PHONE NO : 615-269-7256 490 CRAIGHEAD SE DECISION MADE: 16-OCT-03 NASHVILLE, TN 37204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXTER STERILE POWDER FREE SURGICAL GLOVES MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K032501(TRADITIONAL) ATTN: STANLEY THAI PHONE NO : 603 339 23328 LOT 6070, JALAN HAJI ABDUL SE DECISION MADE: 17-OCT-03 MANAN, 6TH MILES OFF JALAN 510(k) STATEMENT MERU, KLANG, SELANGOR, MALAYSIA 41050 DEVICE: MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE K MCKINLEY, INC. 510(k) NO: K033039(SPECIAL) ATTN: ANDREW N LAMBORNE PHONE NO : 303-420-9569 4080 YOUNGFIELD ST. SE DECISION MADE: 07-OCT-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBLA N7000 MEDCARE FLAGA 510(k) NO: K024322(TRADITIONAL) ATTN: KUMAR KULKARNI PHONE NO : 269-968-3855 46 LOCH HAVEN LN. SE DECISION MADE: 27-OCT-03 BATTLE CREEK, MI 49015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDELA CLARIO HOME CARE PUMP MEDELA AG 510(k) NO: K033179(ABBREVIATED) ATTN: WERNER FREI PHONE NO : 414 176 95151 EXT2 LAETTICHSTRASSE 4 SE DECISION MADE: 15-OCT-03 CH-6340 BAAR, SWITZERLAND 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAS PAR TDM MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K032826(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 09-OCT-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MEDS-4-INF+ MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K032055(TRADITIONAL) ATTN: C. A. TEKLINSKI PHONE NO : 619-665-4912 9811 W. CHARLESTON #2387 SE DECISION MADE: 03-OCT-03 LAS VEGAS, NV 89117 510(k) STATEMENT DEVICE: MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM MEDICAL LASER TECHNOLOGIES, LLC 510(k) NO: K032599(TRADITIONAL) ATTN: MARK ROHRER PHONE NO : 205-290-8251 516 SCOTT STREET SE DECISION MADE: 29-OCT-03 HOMEWOOD, AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSS MEDICAL SCIENTIFIC, INC. 510(k) NO: K031564(SPECIAL) ATTN: PAUL NARDELLA PHONE NO : 508-880-7313 125 JOHN HANCOCK RD. SE DECISION MADE: 07-OCT-03 TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-HEAT INFANT HEEL WARMER MEDIHEAT, INC. 510(k) NO: K032989(TRADITIONAL) ATTN: UMA RAMACHANDRAN PHONE NO : 706-226-1800 505 HILL ROAD SE DECISION MADE: 22-OCT-03 DALTON, GA 30722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC, INC. RACER BILIARY STENT SYSTEM ("RACER"), MODEL XD#Y MEDTRONIC AVE, INC. 510(k) NO: K032768(SPECIAL) ATTN: SARAH SHEPHARD PHONE NO : 707-591-7465 3576 UNOCAL PLACE SE DECISION MADE: 09-OCT-03 SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 MEDTRONIC MINIMED 510(k) NO: K032164(TRADITIONAL) ATTN: GERDA P RESCH PHONE NO : 818-362-5958 18000 DEVONSHIRE ST. SE DECISION MADE: 23-OCT-03 NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 MEDTRONIC MINIMED 510(k) NO: K032484(TRADITIONAL) ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112 18000 DEVONSHIRE ST. SE DECISION MADE: 28-OCT-03 NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 MEDTRONIC MINIMED 510(k) NO: K032485(TRADITIONAL) ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112 18000 DEVONSHIRE ST. SE DECISION MADE: 28-OCT-03 NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL MEDTRONIC NEUROLOGICAL 510(k) NO: K033016(TRADITIONAL) ATTN: PAM SCHAUB PHONE NO : 787-847-8817 710 MEDTRONIC PARKWAY, LN145 SE DECISION MADE: 30-OCT-03 MINNEAPOLIS, MN 55432-5604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SUR MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K033264(SPECIAL) ATTN: PREETI JAIN PHONE NO : 763-391-9000 7611 NORTHLAND DR. SE DECISION MADE: 31-OCT-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC S MEDTRONIC, INC. 510(k) NO: K032138(TRADITIONAL) ATTN: DEBORAH KIDDER PHONE NO : 763-514-9463 4000 LEXINGTON AVE., NORTH SE DECISION MADE: 09-OCT-03 SHOREVIEW, MN 55126-2893 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM MEDTRONIC, INC. 510(k) NO: K032312(SPECIAL) ATTN: KRISTINA MOLLNER PHONE NO : 763-514-4189 7000 CENTRAL AVENUE N. SE DECISION MADE: 21-OCT-03 FRIDLEY, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKG SPEAKS MEDTRONIC, INC. 510(k) NO: K032926(SPECIAL) ATTN: KRISTYN BENSON PHONE NO : 763-514-4617 7000 CENTRAL AVE. NE SE DECISION MADE: 15-OCT-03 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MED MEDX ELECTRONICS, INC. 510(k) NO: K032231(TRADITIONAL) ATTN: ANITA SALTMARCHE PHONE NO : 888 363 3112 3535 LAIRD ROAD SE DECISION MADE: 03-OCT-03 UNIT 2 510(k) SUMMARY AVAILABLE FROM FDA MISSISSAUGA, CANADA L5L 5Y7 DEVICE: MODIFICATION TO: HORIZON 9000WS MENNEN MEDICAL LTD. 510(k) NO: K032997(SPECIAL) ATTN: ASHER KASSEL PHONE NO : 4 HAYARDEN ST. SE DECISION MADE: 15-OCT-03 P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA YAVNE, ISRAEL 81228 DEVICE: MERCATOR HEALTHCARE MALE LATEX CONDOM MERCATOR HEALTHCARE LTD. 510(k) NO: K031369(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 31-OCT-03 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM MERIDAN MEDICAL 510(k) NO: K032427(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 09-OCT-03 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K031922(SPECIAL) ATTN: JOHN W NICHOLSON PHONE NO : 801-253-2600 1600 WEST MERIT PKWY. SE DECISION MADE: 01-OCT-03 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FIL META BIOMED CO., LTD. 510(k) NO: K032603(TRADITIONAL) ATTN: JENNY SHON PHONE NO : 718-639-7460 41-19, 77TH STREET SE DECISION MADE: 07-OCT-03 ELMHURST, NY 11373 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT C META BIOMED CO., LTD. 510(k) NO: K032605(TRADITIONAL) ATTN: JENNY SHON PHONE NO : 718-639-7460 41-19, 77TH STREET SE DECISION MADE: 08-OCT-03 ELMHURST, NY 11373 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR MICRO CURRENT TECHNOLOGY, INC. 510(k) NO: K033253(TRADITIONAL) ATTN: DAVID SUZUKI PHONE NO : 206-938-5800 4822 CALIFORNIA AVE., S.W. SE DECISION MADE: 21-OCT-03 SEATTLE, WA 98116 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MICROGENICS CYCLOSPORINE CONTROL KIT MICROGENICS CORP. 510(k) NO: K032842(TRADITIONAL) ATTN: DAVID CASAL PHONE NO : 510-979-5012 46360 FREMONT BLVD. SE DECISION MADE: 17-OCT-03 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K032590(TRADITIONAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184 75 COLUMBIA SE DECISION MADE: 22-OCT-03 ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMASSAGE ENERGY PRODUCT, MODEL HY5000 MIGUN MEDICAL INSTRUMENT CO. LTD. 510(k) NO: K032449(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-546-9810 5905 FAWN LANE SE DECISION MADE: 22-OCT-03 CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESENS-IONOMER MILTON HODOSH, M.D. 510(k) NO: K032175(TRADITIONAL) ATTN: MILTON HODOSH PHONE NO : 401-781-3591 243 ELWOOD AVE. SE DECISION MADE: 09-OCT-03 PROVIDENCE, RI 02907 510(k) STATEMENT DEVICE: BIO-INTRAFIX TIBIAL SCREW AND SHEATH MITEK WORLDWIDE 510(k) NO: K032167(TRADITIONAL) ATTN: KAREN K SYLVIA PHONE NO : 781-251-2704 A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 15-OCT-03 249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA NORWOOD, MA 02062 DEVICE: MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 401 MK-DENT GMBH 510(k) NO: K032234(TRADITIONAL) ATTN: MARTINA GUNDEROTH PHONE NO : 49 451 3882860 KATHARINENSTR. 5 SE DECISION MADE: 02-OCT-03 LUBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESTATION 126S VIDEOPHONE MOTION MEDIA TECHNOLOGY INC. 510(k) NO: K031863(TRADITIONAL) ATTN: STUART R ROSS PHONE NO : 910-395-6100 6714 NETHERLANDS DRIVE SE DECISION MADE: 10-OCT-03 WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY BREAST COIL, MODEL BBC MRI DEVICES CORP. 510(k) NO: K032576(SPECIAL) ATTN: TOM SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 23-OCT-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL MRI DEVICES CORP. 510(k) NO: K033151(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 10-OCT-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: HAC-12 AND HAC-30 HEAD ARRAY COIL MRI DEVICES CORP. 510(k) NO: K033152(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 10-OCT-03 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: DIO-DENT 10 DENTAL DIODE LASER MSQ (M2) LTD. 510(k) NO: K031819(TRADITIONAL) ATTN: ARAVA HACOHEN PHONE NO : 972 9 7718130 117 AHUZAH ST. SE DECISION MADE: 30-OCT-03 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPHY-MATE NAKANISHI, INC. 510(k) NO: K032395(TRADITIONAL) ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380 700 SHIMOHINATA SE DECISION MADE: 17-OCT-03 KANUMA-SHI, TOCHIGI-KEN, JAPAN 322510(k) STATEMENT DEVICE: MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM NDO SURGICAL, INC. 510(k) NO: K032820(SPECIAL) ATTN: ERIC BANNON PHONE NO : 508-337-8881 125 HIGH ST., SE DECISION MADE: 23-OCT-03 SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA MANSFIELD, MA 02048 DEVICE: SUPEROPEN 0.23T, MODEL NAM-P023A NEUSOFT DIGITAL MEDICAL SYSTEMS CO510(k) NO: K033315(TRADITIONAL) ATTN: WANG ZHIQIANG PHONE NO : 86 24 83665003 NO.3-11, WENHUA ROAD SE DECISION MADE: 29-OCT-03 HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW DEVICE: NBD DISPOSABLE RF CANNULAE NEW BUSINESS DEVELOPMENT, LLC 510(k) NO: K032196(TRADITIONAL) ATTN: TIMOTHY B LUSBY PHONE NO : 678-852-5504 605 INDUSTRIAL COURT SE DECISION MADE: 09-OCT-03 WOODSTOCK, GA 30189 510(k) STATEMENT DEVICE: GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 NIDEK, INC. 510(k) NO: K032085(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 03-OCT-03 LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO DISPOSABLE SYRINGES NIPRO MEDICAL CORP. 510(k) NO: K030683(TRADITIONAL) ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 31-OCT-03 LEXINGTON, KY 40514-1268 510(k) STATEMENT DEVICE: MODEL 3100 WRISTOX PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K030668(TRADITIONAL) ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166 2605 FERNBROOK LANE, NORTH SE DECISION MADE: 17-OCT-03 MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CZR PRESS NORITAKE CO., INC. 510(k) NO: K033049(TRADITIONAL) ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400 3050 K STREET, NW, STE 400 SE DECISION MADE: 24-OCT-03 WASHINGTON, DC 20007 510(k) STATEMENT DEVICE: CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5 NOUVAG AG 510(k) NO: K022505(TRADITIONAL) ATTN: ERICH FORSTER PHONE NO : 004 156 2019500 REUSSWEHRSTRASSE 1 SE DECISION MADE: 01-OCT-03 GEBENSTORF, SWITZERLAND 5412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN NOVAMIN TECHNOLOGY, INC. 510(k) NO: K033295(TRADITIONAL) ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551 13709 PROGRESS BLVD, # 23 SE DECISION MADE: 28-OCT-03 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NORMED COMPRESSION BONE SCREW SYSTEM NOVIACE CORPORATION 510(k) NO: K032634(TRADITIONAL) ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306 809 CARTER LANE SE DECISION MADE: 06-OCT-03 PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. 510(k) NO: K032083(TRADITIONAL) ATTN: LAETITIA BERNARD PHONE NO : 858-271-7070 10065 OLD GROVE RD. SE DECISION MADE: 24-OCT-03 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE CEMENT RESTRICTOR NUVASIVE, INC. 510(k) NO: K032180(TRADITIONAL) ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918 10065 OLD GROVE RD., SUITE A SE DECISION MADE: 07-OCT-03 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. 510(k) NO: K032356(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST. SE DECISION MADE: 28-OCT-03 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843 DEVICE: EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS AC OLYMPUS OPTICAL CO., LTD. 510(k) NO: K033225(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 TWO CORPORATE CENTER DR. SE DECISION MADE: 16-OCT-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOS OLYMPUS OPTO-ELECTRONICS CO., LTD.510(k) NO: K032177(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 TWO CORPORATE CENTER DR. SE DECISION MADE: 02-OCT-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTENT SDS BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K033212(SPECIAL) ATTN: JIM CLOSSICK PHONE NO : 954-730-0711 5363 N.W. 35TH AVE. SE DECISION MADE: 30-OCT-03 FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORT CASSETTE OREX COMPUTED RADIOGRAPHY LTD 510(k) NO: K032654(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 09-OCT-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL ORION DIAGNOSTICA, DIV. ORION CORP510(k) NO: K031607(TRADITIONAL) ATTN: ANNIKKA RANTAMA PHONE NO : 358 104 292736 KOIVU-MANKKAAN TIE 6 SE DECISION MADE: 10-OCT-03 ESPOO, FINLAND 02200 510(k) STATEMENT DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K033127(TRADITIONAL) ATTN: SARAH PARSONS PHONE NO : 585-453-3154 100 INDIGO CREEK DR. SE DECISION MADE: 31-OCT-03 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K032993(TRADITIONAL) ATTN: SARAH PARSONS PHONE NO : 585-453-3154 100 INDIGO CREEK DR. SE DECISION MADE: 31-OCT-03 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STS SCREW ORTHO-PRO LLC 510(k) NO: K032682(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 22-OCT-03 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SC TOTAL HIP SYSTEM ORTHOPEDIC ALLIANCE LLC 510(k) NO: K031474(TRADITIONAL) ATTN: ROGER WILLIAMS PHONE NO : 909-304-9001 41558 EASTMAN DRIVE SE DECISION MADE: 15-OCT-03 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA MARIETTA, CA 92562 DEVICE: NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE ORTHOSOFT, INC. 510(k) NO: K032917(SPECIAL) ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074 75 QUEEN ST., SUITE 3300 SE DECISION MADE: 21-OCT-03 MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MORALES PROTRACTION FACEMASK ORTOSIM, S.A. DE C.V. 510(k) NO: K032392(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 22-OCT-03 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: IMMIX PLASTIFILM OSTEOBIOLOGICS, INC. 510(k) NO: K032673(SPECIAL) ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131 UNIVERSITY BUSINESS PARK SE DECISION MADE: 02-OCT-03 12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78249-3308 DEVICE: PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR OSYPKA MEDICAL, INC. 510(k) NO: K033130(SPECIAL) ATTN: MARKUS J OSYPKA PHONE NO : 858-454-0021 7855 IVANHOE AVE. SE DECISION MADE: 31-OCT-03 SUITE 226 510(k) SUMMARY AVAILABLE FROM FDA LA JOLLA, CA 92037 DEVICE: MECHANICAL WHEEHCHAIR PACIFIC MEDICAL SUPPLIERS, INC. 510(k) NO: K033141(TRADITIONAL) ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059 30 NORTHPORT ROAD SE DECISION MADE: 30-OCT-03 SOUND BEACH, NY 11789-1734 510(k) STATEMENT DEVICE: PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS PARAGON MEDICAL, INC. 510(k) NO: K032119(TRADITIONAL) ATTN: DAVID C FURR PHONE NO : 260-459-9475 7822 LADUE GLEN SE DECISION MADE: 29-OCT-03 FORT WAYNE, IN 46804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIAR PERCLOSE, INC. 510(k) NO: K032929(SPECIAL) ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331 400 SAGINAW SE DECISION MADE: 22-OCT-03 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K032374(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 410-837-1751 1301 DEFENSE HIGHWAY SE DECISION MADE: 22-OCT-03 GAMBRILLS, MD 21054-1928 510(k) STATEMENT DEVICE: RUBBERCARE POWDERED LATEX EXAMINATION GLOVES PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K032201(TRADITIONAL) ATTN: PETER YEW NIENG CHOON PHONE NO : 606 677 2781 EMPAT, SENAWANG INDUSTRIAL SE DECISION MADE: 10-OCT-03 ESTATE, 70450 SEREMBAN, NEGERI 510(k) SUMMARY AVAILABLE FROM FDA SEMBILAN DARUL KHUSUS MALAYSIA, MALI DEVICE: "PHILIPS PLUS" COMPUTED TOMOGRAPHY SYSTEM PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K033326(TRADITIONAL) ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528 595 MINER RD. SE DECISION MADE: 29-OCT-03 HIGHLAND HGTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT M PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K032858(SPECIAL) ATTN: HAUKE SCHIK PHONE NO : 497 031 4632031 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 10-OCT-03 BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACURA ELITE GRAVITY COMPENSATING RESERVOIR PHOENIX BIOMEDICAL CORP. 510(k) NO: K030468(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 15-OCT-03 P.O. BOX 80390 510(k) STATEMENT VALLEY FORGE, PA 19484 DEVICE: NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03 POLYGANICS BV 510(k) NO: K032115(TRADITIONAL) ATTN: JAN BART HAK PHONE NO : 31 50 5886588 L.J. ZIELSTRAWEG 1 SE DECISION MADE: 10-OCT-03 GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ SPLINT & EZ SPLINT PM POWER PRODUCTS, INC.-SPLINTEK 510(k) NO: K022809(TRADITIONAL) ATTN: CAROLANN KOTULA PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 17-OCT-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: PROWESS PROWESS, INC. 510(k) NO: K032456(TRADITIONAL) ATTN: W. JAMES BISHOP PHONE NO : 530-898-0660 1370 RIDGEWOOD DR., #20 SE DECISION MADE: 16-OCT-03 CHICO, CA 95973-7803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LTV-1000 VENTILATOR PULMONETIC SYSTEMS, INC. 510(k) NO: K032226(TRADITIONAL) ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305 17400 MEDINA RD. SE DECISION MADE: 16-OCT-03 SUITE 100 510(k) STATEMENT MINNEAPOLIS, MN 55447 DEVICE: GLYCOHEMOSURE HBA1C CONTROL QUANTIMETRIX CORP. 510(k) NO: K032791(TRADITIONAL) ATTN: GEBHARD NEYER PHONE NO : 310-536-0006 2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 30-OCT-03 REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPR SYSTEM RADIANCY (ISRAEL) LTD. 510(k) NO: K033181(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 24-OCT-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIUS COUGAR WIRE RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K032899(SPECIAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY TRAIL SE DECISION MADE: 17-OCT-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH REMCO ITALIA S.P.A. 510(k) NO: K032200(ABBREVIATED) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 03-OCT-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NASAL JACKS MASK RESMED LTD. 510(k) NO: K032433(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2400 14040 DANIELSON ST. SE DECISION MADE: 24-OCT-03 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSET SPIRIT SYSTEM RESMED LTD. 510(k) NO: K032480(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 16-OCT-03 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICO WITH MARS, MODEL 7300 RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K030886(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-697-6442 5 TECHNOLOGY DR. SE DECISION MADE: 07-OCT-03 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTMONITOR 2 PROFESSIONAL SERIES (PS) RESPIRONICS, INC. 510(k) NO: K032403(ABBREVIATED) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 27-OCT-03 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AN RICH-MAR CORP. 510(k) NO: K032941(SPECIAL) ATTN: DAVID RICHARDS PHONE NO : 800-762-4665 P.O. BOX 879 SE DECISION MADE: 22-OCT-03 INOLA, OK 74036-0879 510(k) STATEMENT DEVICE: POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.91 RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K030082(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 30-OCT-03 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONLINE TDM AMIKA ROCHE DIAGNOSTICS CORP. 510(k) NO: K032279(TRADITIONAL) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 10-OCT-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE DIAGNOSTICS OMNI S ANALYZER ROCHE DIAGNOSTICS CORP. 510(k) NO: K032311(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742 P.O. BOX 50457 SE DECISION MADE: 17-OCT-03 9115 HAGUE RD. 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS ROCHE DIAGNOSTICS CORP. 510(k) NO: K032437(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742 9115 HAGUE RD. SE DECISION MADE: 08-OCT-03 PO BX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K033009(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 16-OCT-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHE ROCHE DIAGNOSTICS CORP. 510(k) NO: K033165(ABBREVIATED) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 14-OCT-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA ALP IFCC GEN.2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K033185(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 14-OCT-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM SANARUS MEDICAL, INC. 510(k) NO: K032506(TRADITIONAL) ATTN: TRENA DEPEL PHONE NO : 925-460-6080 5880 WEST LAS POSITAS BLVD. SE DECISION MADE: 09-OCT-03 SUITE 52 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI SATELEC 510(k) NO: K032465(TRADITIONAL) ATTN: JACQUELINE E MASSE PHONE NO : 781-239-8108 70 WALNUT ST. SE DECISION MADE: 21-OCT-03 WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOMA ANTERIOR CERVICAL PLATE SYSTEM SEASPINE 510(k) NO: K032368(TRADITIONAL) ATTN: DIANA SMITH PHONE NO : 619-251-9132 727 PARK BLVD. SE DECISION MADE: 09-OCT-03 SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 SECTRA AB 510(k) NO: K033088(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD. SE DECISION MADE: 29-OCT-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECTRA ORTHOPEDIC PACKAGE SECTRA-IMTEC AB 510(k) NO: K031590(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD. SE DECISION MADE: 02-OCT-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL EXAMINATION GLOVE SHANGHAI FOREMOST PLASTIC INDUSTRI510(k) NO: K032071(ABBREVIATED) ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250 30798 US HWY. 19N SE DECISION MADE: 10-OCT-03 PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES SHANGHAI GIANTMAX PLASTIC PRODUCT 510(k) NO: K032745(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 17-OCT-03 SUITE 200 510(k) STATEMENT GREAT NECK, NY 11021 DEVICE: SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES SHANGHAI GIANTMAX PLASTIC PRODUCT 510(k) NO: K032746(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 17-OCT-03 SUITE 200 510(k) STATEMENT GREAT NECK, NY 11021 DEVICE: PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW SHANGHAI JIAWANG INDUSTRIAL CO. LT510(k) NO: K032792(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D EMERALD SE DECISION MADE: 15-OCT-03 SPARKS,, NV 89434-9550 510(k) STATEMENT DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR SHEN WEI (USA), INC. 510(k) NO: K032024(TRADITIONAL) ATTN: BELLE M CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 29-OCT-03 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR SHEN WEI (USA), INC. 510(k) NO: K032084(TRADITIONAL) ATTN: BELLE CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 29-OCT-03 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: RHYTHM TOUCH Q 2-WAY SHOCKIM ENTERPRISES, LTD. 510(k) NO: K032178(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 15-OCT-03 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM AVANTO MR SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032428(TRADITIONAL) ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769 51 VALLEY STREAM PKWY. SE DECISION MADE: 16-OCT-03 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROMLC SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032790(SPECIAL) ATTN: KEN NEHMER PHONE NO : 925-602-8011 4040 NELSON AVE. SE DECISION MADE: 02-OCT-03 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLINE ANTARES WITH CLARIFY VE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K033196(TRADITIONAL) ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229 22010 S.E. 51ST ST. SE DECISION MADE: 16-OCT-03 ISSAQUAH, WA 98029-7298 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONKLUSION PEDICLE SCREW SYSTEM SIGNUS MEDICAL LLC. 510(k) NO: K031455(TRADITIONAL) ATTN: THOMAS HOGHAUG PHONE NO : 952-974-9456 6713 LAKEWAY DR. SE DECISION MADE: 22-OCT-03 CHANHASSEN, MN 55317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPHOS XG DS/CEPH SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K033073(SPECIAL) ATTN: SHEILA M HEMEON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 10-OCT-03 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIVEX SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K032387(TRADITIONAL) ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365 150 MINUTEMAN RD. SE DECISION MADE: 29-OCT-03 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS II POROUS PLUS HA KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K032683(ABBREVIATED) ATTN: JANET JOHNSON-AKIL PHONE NO : 901-399-5153 1450 E. BROOKS RD. SE DECISION MADE: 15-OCT-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIGEN STRAIGHT HUMERAL NAIL SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K032722(SPECIAL) ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153 1450 E. BROOKS RD. SE DECISION MADE: 01-OCT-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIEFIX SOFRADIM PRODUCTION 510(k) NO: K032093(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 22-OCT-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIRAZ-JAVA SPINAL FIXATION SYSTEM SPINE NEXT SA 510(k) NO: K031265(TRADITIONAL) ATTN: DIANE JOHNSON PHONE NO : 410-409-8276 104 GREENWOOD CREEK RD. SE DECISION MADE: 09-OCT-03 QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINERX-LDM SPINERX TECHNOLOGY 510(k) NO: K031862(TRADITIONAL) ATTN: HUGHIE WATSON PHONE NO : 713-983-0939 6100 BRITTMOORE RD SE DECISION MADE: 31-OCT-03 BLDG S 510(k) SUMMARY AVAILABLE FROM FDA HOUSTON, TX 77041 DEVICE: PLUS PIVOT LINK UNIVERSAL SYSTEM SPINEVISION, INC. 510(k) NO: K032398(TRADITIONAL) ATTN: LYNETTE WHITAKER PHONE NO : 574-269-9776 3003 SUMMIT BLVD. STE 1500 SE DECISION MADE: 31-OCT-03 ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM STANBIO LABORATORY 510(k) NO: K032482(TRADITIONAL) ATTN: KIRK JOHNSON PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 24-OCT-03 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT STELKAST COMPANY 510(k) NO: K031901(SPECIAL) ATTN: DONALD A STEVENS PHONE NO : 724-941-6368 200 HIDDEN VALLEY RD. SE DECISION MADE: 10-OCT-03 MCMURRAY, PA 15317 510(k) STATEMENT DEVICE: MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-11 STELLARTECH RESEARCH CORP. 510(k) NO: K032721(SPECIAL) ATTN: GARY A SEEGER PHONE NO : 408-331-3138 1346 BORDEAUX DR. SE DECISION MADE: 06-OCT-03 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERISIL ANTIMICROBIAL TUBING AND BOTTLE STERISIL 510(k) NO: K031681(TRADITIONAL) ATTN: BRAD DOWNS PHONE NO : 719-481-0937 200 S. WILCOX SE DECISION MADE: 30-OCT-03 CASTLE ROCK, CO 80104 510(k) STATEMENT DEVICE: STICK FLOW STICK TECH LTD. 510(k) NO: K031341(TRADITIONAL) ATTN: WILLIAM TROETEL PHONE NO : 914-664-1640 80 PARKWAY WEST SE DECISION MADE: 29-OCT-03 MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI SYNOCTA MESO ABUTMENTS STRAUMANN USA 510(k) NO: K033243(SPECIAL) ATTN: LINDA JALBERT PHONE NO : 781-890-0001 RESERVOIR PLACE, SE DECISION MADE: 20-OCT-03 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02154 DEVICE: STRYKER FLEXIBLE URETEROSCOPE STRYKER ENDOSCOPY 510(k) NO: K031278(TRADITIONAL) ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288 5900 OPTICAL CT. SE DECISION MADE: 16-OCT-03 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONESOURCE HAC FAST SETTING CEMENT STRYKER INSTRUMENTS 510(k) NO: K032366(TRADITIONAL) ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226 4100 EAST MILHAM AVE. SE DECISION MADE: 30-OCT-03 KALAMAZOO, MI 49087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUN-RAIN ULTRASONIC THERAPY, SU-100 SUN-RAIN SYSTEM CORP. 510(k) NO: K024013(TRADITIONAL) ATTN: R. JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 31-OCT-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: OPTIBAND LC SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K032407(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 W. COLLINS AVE. SE DECISION MADE: 06-OCT-03 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAMON FT SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K032408(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 W. COLLINS AVE. SE DECISION MADE: 15-OCT-03 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS SYNTHES (USA) 510(k) NO: K032559(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 22-OCT-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES SYNTHES (USA) 510(k) NO: K033065(TRADITIONAL) ATTN: BONNIE SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 29-OCT-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES SYNTHES (USA) 510(k) NO: K033121(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 20-OCT-03 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES SYNTHES (USA) 510(k) NO: K033160(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 09-OCT-03 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: POWDER FREE LATEX EXAM GLOVES TAN SIN LIAN INDUSTRIES SDN. BHD. 510(k) NO: K031335(TRADITIONAL) ATTN: LEE TAN PHONE NO : 215-922-6053 1133, NORTH 4TH ST. SE DECISION MADE: 16-OCT-03 PHILADEPHIA, PA 19123 510(k) STATEMENT DEVICE: ORTRAUTEK ORTHOGNATHIC SYSTEM TEKKA 510(k) NO: K031989(TRADITIONAL) ATTN: FAYYAZ MEMON PHONE NO : 301-263-0544 6512 BANNOCKBURN DRIVE SE DECISION MADE: 28-OCT-03 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND G TENGHI CO. LTD 510(k) NO: K033069(TRADITIONAL) ATTN: LIN HEIAO-FENG PHONE NO : 886 4 22754992 112 YI-CHUNG EAST ROAD, SE DECISION MADE: 24-OCT-03 TAIPING CITY 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) DEVICE: NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/ THE FIRST YEARS, INC. 510(k) NO: K033131(SPECIAL) ATTN: ROBIN C CONNER PHONE NO : 508-588-1220 ONE KIDDIE DR. SE DECISION MADE: 30-OCT-03 AVON, MA 02322 510(k) STATEMENT DEVICE: SONOSURG SYSTEM THE OLYMPUS OPTICAL CO. 510(k) NO: K032066(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 516-844-5477 ENDOSCOPE DIVISION SE DECISION MADE: 03-OCT-03 TWO CORPORATE CENTER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA MELVILLE, NY 11747-3157 DEVICE: MOSFET AUTOSENSE WIRELESS THOMSON & NIELSEN ELECTRONICS, LTD510(k) NO: K032725(SPECIAL) ATTN: MARY HERBERT PHONE NO : 613 596 4563 25-B NORTHSIDE RD. SE DECISION MADE: 03-OCT-03 OTTAWA, ONTARIO, CANADA K2H 8S1 510(k) STATEMENT DEVICE: TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM TITRONICS RESEARCH & DEVELOPMENT C510(k) NO: K032471(TRADITIONAL) ATTN: JOSEPH R TITONE PHONE NO : 319-683-2702 2046 REDWING HOLLOW S.W. SE DECISION MADE: 10-OCT-03 OXFORD, IA 52322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HLS NOETOS SYSTEM TORNIER S.A. 510(k) NO: K032079(TRADITIONAL) ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898 ZIRST-161, RUE LAVOISIER SE DECISION MADE: 02-OCT-03 MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT TRACK CORPORATION 510(k) NO: K033263(TRADITIONAL) ATTN: JON EMERY PHONE NO : 616-844-2471 17024 TAFT ROAD SE DECISION MADE: 31-OCT-03 SPRING LAKE, MI 49456 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS TURBO WHEELCHAIR CO., INC. 510(k) NO: K032731(ABBREVIATED) ATTN: JANE HERMES PHONE NO : 843-322-0486 76 MERIDIAN RD. SE DECISION MADE: 30-OCT-03 BEAUFORT, SC 29907 510(k) STATEMENT DEVICE: TARAS THREADED FIXATION PIN UNION SURGICAL LLC 510(k) NO: K032532(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 834 CHESTNUT STREET SE DECISION MADE: 22-OCT-03 SUITE G114 510(k) SUMMARY AVAILABLE FROM FDA PHILADELPHIA, PA 19107 DEVICE: EPT CERTAINTY PREGNANCY TEST UNIPATH LTD. 510(k) NO: K032939(SPECIAL) ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564 PRIORY BUSINESS PARK SE DECISION MADE: 20-OCT-03 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT DEVICE: UUHC REPROCESSED COMPRESSION SLEEVE DEVICES UNIVERSITY OF UTAH HOSPITALS AND C510(k) NO: K031189(TRADITIONAL) ATTN: JACK SPEER PHONE NO : 801-582-6470 1800 EAST 900 SOUTH SE DECISION MADE: 16-OCT-03 SALT LAKE, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNOMEDICAL MONICA INFUSION SET UNOMEDICAL A/S 510(k) NO: K032854(SPECIAL) ATTN: JOHN M LINDSKOG PHONE NO : 45 46 427810 AAHOLMVEJ 1-3, OSTED SE DECISION MADE: 09-OCT-03 ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACURECT VACUUM CONSTRICTION DEVICE VACURECT MANUFACTURING (PTY) LTD. 510(k) NO: K032776(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 03-OCT-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE VAN OOSTVEEN MEDICAL B.V. 510(k) NO: K023139(TRADITIONAL) ATTN: M.J. VAN OOSTVEEN PHONE NO : 00 31 297282101 HERENWEG 269 SE DECISION MADE: 22-OCT-03 WILNIS, HOLLAND, NETHERLANDS 3648 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PR VASCULAR SOLUTIONS, INC. 510(k) NO: K032805(SPECIAL) ATTN: DEBORAH JENSEN PHONE NO : 763-656-4349 6464 SYCAMORE COURT SE DECISION MADE: 01-OCT-03 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGORMIST COMPRESSOR NEBULIZER VEGA TECHNOLOGIES, INC. 510(k) NO: K031413(TRADITIONAL) ATTN: JOSEPH LU PHONE NO : 886 2 25416996 11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 07-OCT-03 TAIPEI, CHINA (TAIWAN) 104 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VELOPEX AQUACUT FLUID ABRASION UNIT VELOPEX INTERNATIONAL, INC. 510(k) NO: K024105(TRADITIONAL) ATTN: TONY URELLA PHONE NO : 407-957-3900 105 EAST 17TH ST. SE DECISION MADE: 09-OCT-03 ST. CLOUD, FL 34769 510(k) STATEMENT DEVICE: VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE VITAL IMAGES, INC. 510(k) NO: K032748(ABBREVIATED) ATTN: STEPHEN S ANDERSON PHONE NO : 763-852-4100 3300 FERNBROOK LN. NORTH SE DECISION MADE: 29-OCT-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: BREAS PV 10I CPAP SYSTEM, MODEL PV 10I VITAL SIGNS, INC. 510(k) NO: K030985(TRADITIONAL) ATTN: ANTHONY P MARTINO PHONE NO : 973-790-1330 20 CAMPUS RD. SE DECISION MADE: 15-OCT-03 TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFADEX SOLUTION FOR LUNG PRESERVATION VITROLIFE AB 510(k) NO: K022730(TRADITIONAL) ATTN: KARL A POSSELT PHONE NO : 908-284-2246 155 CIDER MILL RD. SE DECISION MADE: 27-OCT-03 RINGOES, NJ 08551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVATIP MICROWAVE ABLATION PROBE VIVANT MEDICAL, INC. 510(k) NO: K032702(SPECIAL) ATTN: STEVEN KIM PHONE NO : 650-694-2900 1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 03-OCT-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER VIVOSONIC, INC. 510(k) NO: K033108(SPECIAL) ATTN: YURI SOKOLOV PHONE NO : 877 255 7685 56 ABERFOYLE CRESCENT SE DECISION MADE: 27-OCT-03 SUITE 620 510(k) SUMMARY AVAILABLE FROM FDA TORONTO, ON, CANADA M8X 2W4 DEVICE: IONOFIL COLOR AC VOCO GMBH 510(k) NO: K033068(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 31-OCT-03 BEND, OR 97702 510(k) STATEMENT DEVICE: RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, VOLUME INTERACTIONS PTE LTD 510(k) NO: K032924(SPECIAL) ATTN: JOHN BABY PHONE NO : 65 622 26962 5 SHENTON WAY SE DECISION MADE: 10-OCT-03 #37-04 UIC BUILDING 510(k) STATEMENT SINGAPORE, SINGAPORE DEVICE: W.O.M. LASER U100PLUS W.O.M. WORLD OF MEDICINE AG 510(k) NO: K032023(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 703-299-0523 320 NORTH COLUMBUS ST. SE DECISION MADE: 01-OCT-03 ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COACH 777-3 WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030756(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 4905 A. SAN JACINTO SE DECISION MADE: 06-OCT-03 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: COACH 777-4 WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030757(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 4905 A. SAN JACINTO SE DECISION MADE: 06-OCT-03 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: F-10 FOLDING POWER CHAIR WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K032441(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 4905 A. SAN JACINTO SE DECISION MADE: 06-OCT-03 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A WIDE CORPORATION 510(k) NO: K032960(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 08-OCT-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM F WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K031963(SPECIAL) ATTN: KATIE LOGEROT PHONE NO : 901-867-4476 5677 AIRLINE RD. SE DECISION MADE: 31-OCT-03 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINICAT DENTOCAT XORAN TECHNOLOGIES, INC. 510(k) NO: K032243(TRADITIONAL) ATTN: PREDRAG SUKOVIC PHONE NO : 734-663-7194 309 N. FIRST STREET SE DECISION MADE: 02-OCT-03 ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRAK SUPPORT CATHETER XTRAK MEDICAL INC. 510(k) NO: K032660(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 29-OCT-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENT ZIMMER, INC. 510(k) NO: K031061(TRADITIONAL) ATTN: STEPHEN MCKELVEY PHONE NO : 574-372-4944 P.O. BOX 708 SE DECISION MADE: 09-OCT-03 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES ZIMMER, INC. 510(k) NO: K032726(TRADITIONAL) ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523 P.O. BOX 708 SE DECISION MADE: 22-OCT-03 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL M SERIES NIBP OPTION ZOLL MEDICAL CORP. 510(k) NO: K032363(TRADITIONAL) ATTN: SEAN REYNOLDS PHONE NO : 978-421-9655 269 MILL ROAD SE DECISION MADE: 31-OCT-03 CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 382 TOTAL WITH SUMMARIES 313 TOTAL WITH STATEMENTS 69
Updated November 5, 2003
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