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510(k)s Final Decisions Rendered for July 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUL-2003 THROUGH 31-JUL-2003 DEVICE: STEREOTACTIC BODY FRAME, MODEL COD. 70-1A 3D LINE USA, INC. 510(k) NO: K031631(TRADITIONAL) ATTN: NADER SALEHI PHONE NO : 410-581-6701 11419 CROWNRIDGE RD., STE.15 SE DECISION MADE: 18-JUL-03 OWINGS MILLS, MD 21117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-REACTIVE PROTEIN (CRP) ABBOTT LABORATORIES 510(k) NO: K030899(TRADITIONAL) ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1920 HURD DR. SE DECISION MADE: 02-JUL-03 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE ACMI CORPORATION 510(k) NO: K030960(TRADITIONAL) ATTN: JOHN DELUCIA PHONE NO : 508-804-2617 136 TURNPIKE RD. SE DECISION MADE: 16-JUL-03 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACON STREP A RAPID TEST DEVICE ACON LABORATORIES, INC. 510(k) NO: K031784(SPECIAL) ATTN: EDWARD TUNG PHONE NO : 858-535-2038 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 14-JUL-03 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330 ACTHERM, INC. 510(k) NO: K031905(SPECIAL) ATTN: RICHARD HSIEH PHONE NO : 886 3 5537315 6TH F, NO 85 SE DECISION MADE: 07-JUL-03 KUAN-MIN 6 ROAD JUBEI 302 510(k) STATEMENT HSINCHU, CHINA (TAIWAN) 302 DEVICE: ACUMED SMALL BONE LOCKING ROD SYSTEM II ACUMED LLC 510(k) NO: K031438(TRADITIONAL) ATTN: ED BOEHMER PHONE NO : 503-627-9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 17-JUL-03 HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "FAST THROW" STAINLESS STEEL SURGICAL SUTURE ADVANCED SURGICAL PRODUCTS, INC. 510(k) NO: K030926(TRADITIONAL) ATTN: JEFFERY S JONES PHONE NO : 650-207-6987 681 MANZANITA AVE. SE DECISION MADE: 21-JUL-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTUR AESCULAP 510(k) NO: K031216(TRADITIONAL) ATTN: GEORG KELLER PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 17-JUL-03 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM AESCULAP, INC. 510(k) NO: K032059(SPECIAL) ATTN: GEORG KELLER PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 25-JUL-03 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATIO ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K032147(SPECIAL) ATTN: STACY L LEWIS PHONE NO : 858-458-7830 10221 WATERIDGE CIR. SE DECISION MADE: 25-JUL-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION ALCON, INC. 510(k) NO: K031193(TRADITIONAL) ATTN: KIM B KRACKE PHONE NO : 817-551-8338 6201 SOUTH FREEWAY SE DECISION MADE: 03-JUL-03 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. 510(k) NO: K032058(SPECIAL) ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 30-JUL-03 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE AMERICAN SYRINGE COMPANY 510(k) NO: K031394(TRADITIONAL) ATTN: DAVID M GARVIN PHONE NO : 305-371-8166 1200 BRICKELL AVE. SE DECISION MADE: 25-JUL-03 SUITE 1480 510(k) STATEMENT MIAMI, FL 33131 DEVICE: AMERITEK SURE-POINT HDR NEEDLE TEMPLATE AMERTEK MEDICAL, INC. 510(k) NO: K031273(TRADITIONAL) ATTN: GREG WIITA PHONE NO : 561-842-7595 2655 NORTH OCEAN DR. SE DECISION MADE: 15-JUL-03 SINGER ISLAND, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLAID A756 SCREENING ADMITTANCE METER AMPLAID 510(k) NO: K031978(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 21-JUL-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER LASER 90 ANDI ELECTROMEDICAL APS 510(k) NO: K030692(TRADITIONAL) ATTN: JEFF WORRELL PHONE NO : 800-662-7283 12415 OLD MERIDIAN ST. SE DECISION MADE: 17-JUL-03 CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A/C ENZYMATIC HOMOCYSTEINE ASSAY ANTICANCER INC 510(k) NO: K030754(TRADITIONAL) ATTN: YUYING TAN PHONE NO : 858-654-2555 7917 OSTROW ST. SE DECISION MADE: 11-JUL-03 SAN DIEGO, CA 92111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJECTOR ANTON MEYER & CO. LTD. 510(k) NO: K023737(TRADITIONAL) ATTN: THOMAS MEYER PHONE NO : 41 32 3329111 HELMSTRASSE 1 SE DECISION MADE: 14-JUL-03 NIDAU, SWITZERLAND CH-2560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K031913(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 621 166 20201/195 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 09-JUL-03 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE ASIA-MED GMBH AND CO KG 510(k) NO: K031716(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LN. SE DECISION MADE: 10-JUL-03 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: OSTEO-G BONE VOID FILLER SYSTEM ASPINE USA, INC. 510(k) NO: K031319(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 4329 GRAYDON RD. SE DECISION MADE: 17-JUL-03 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K032082(SPECIAL) ATTN: JAMES R VEALE PHONE NO : 719-495-3438 49 PLAIN STREET SE DECISION MADE: 30-JUL-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-13 AVANTEC VASCULAR CORP. 510(k) NO: K030638(TRADITIONAL) ATTN: JAMES M SHY PHONE NO : 408-743-3100 1049 KIEL CT. SE DECISION MADE: 09-JUL-03 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETY INTRODUCER NEEDLE B. BRAUN MEDICAL, INC. 510(k) NO: K030135(TRADITIONAL) ATTN: AMY K SMITH PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 15-JUL-03 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B. BRAUN NERVE BLOCK CATHETER B. BRAUN MEDICAL, INC. 510(k) NO: K030830(TRADITIONAL) ATTN: PATRICIA D WILSON PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 15-JUL-03 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230- BAYLIS MEDICAL CO., INC. 510(k) NO: K031950(ABBREVIATED) ATTN: KRIS SHAH PHONE NO : 905 602 4875 5160 EXPLORER DR. #33 SE DECISION MADE: 17-JUL-03 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT DEVICE: SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT BECKMAN COULTER, INC. 510(k) NO: K031870(SPECIAL) ATTN: MARY BETH TANG PHONE NO : 714-961-3777 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 15-JUL-03 BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER BECKMAN COULTER, INC. 510(k) NO: K032013(SPECIAL) ATTN: LOURDES COBA PHONE NO : 305-380-4552 11800 SW 147TH AVE. SE DECISION MADE: 24-JUL-03 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG BECTON DICKINSON & CO. 510(k) NO: K031530(TRADITIONAL) ATTN: MONICA EVELYN GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 10-JUL-03 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POS BECTON, DICKINSON AND COMPANY 510(k) NO: K031589(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 11-JUL-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON AND COMPANY 510(k) NO: K031679(TRADITIONAL) ATTN: BRADFORD SPRING PHONE NO : 410-316-4206 7 LOVETON CIR. SE DECISION MADE: 16-JUL-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMET BECTON, DICKINSON AND COMPANY 510(k) NO: K031699(TRADITIONAL) ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 30-JUL-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE BECTON, DICKINSON AND COMPANY 510(k) NO: K031912(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 21-JUL-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROHEATER BELMONT INSTRUMENT CORP. 510(k) NO: K031478(TRADITIONAL) ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212 780 BOSTON RD. SE DECISION MADE: 02-JUL-03 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-LOGIC INSERT EARPHONES BIO-LOGIC SYSTEMS CORP. 510(k) NO: K031352(TRADITIONAL) ATTN: ERIK C GUNDERSEN PHONE NO : 847-949-5200 ONE BIO-LOGIC PLAZA SE DECISION MADE: 16-JUL-03 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTR510(k) NO: K030076(TRADITIONAL) ATTN: SUSAN B FENTRESS PHONE NO : 901-680-7319 6075 POPLAR AVE. SE DECISION MADE: 07-JUL-03 SUITE 500 510(k) STATEMENT MEMPHIS, TN 38119 DEVICE: VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K031410(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 10-JUL-03 HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT MP CULTURE BOTTLES (PLASTIC) BIOMERIEUX, INC. 510(k) NO: K031737(TRADITIONAL) ATTN: JOCELYN JENNINGS PHONE NO : 919-620-2968 100 RODOLPHE ST. SE DECISION MADE: 14-JUL-03 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS BIOMET, INC. 510(k) NO: K031734(SPECIAL) ATTN: GARY BAKER PHONE NO : 574-372-1568 56 EAST BELL DR. SE DECISION MADE: 01-JUL-03 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: AIRBRUSH LIPOSCULPTOR SYSTEM BIOSCULPTURE TECHNOLOGY, INC. 510(k) NO: K031881(TRADITIONAL) ATTN: ROBERT CUCIN PHONE NO : 212-977-5400 120 CENTRAL PARK SOUTH SE DECISION MADE: 28-JUL-03 NEW YORK, NY 10019 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER BIOSENSE WEBSTER, INC. 510(k) NO: K031161(SPECIAL) ATTN: WILLIAM WELCH PHONE NO : 909-839-8604 3333 DIAMOND CANYON RD. SE DECISION MADE: 22-JUL-03 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL SEMEN ANALYSIS (GSA) KIT BIOSHAF LTD. 510(k) NO: K024337(TRADITIONAL) ATTN: TOM TSAKERIS PHONE NO : 301-330-2076 16809 BRIARDALE RD. SE DECISION MADE: 03-JUL-03 ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAOS 70 BLUE X IMAGING SRL 510(k) NO: K031118(TRADITIONAL) ATTN: AL SOSA PHONE NO : 847-459-3889 251 E. DUNDEE RD. SE DECISION MADE: 08-JUL-03 SUITE #6 510(k) SUMMARY AVAILABLE FROM FDA WHEELING, IL 60090 DEVICE: ULTRAFLEX PRECISION COLONIC STENT BOSTON SCIENTIFIC CORP. 510(k) NO: K030769(TRADITIONAL) ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 14-JUL-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 BOSTON SCIENTIFIC CORP. 510(k) NO: K031844(SPECIAL) ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338 10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 15-JUL-03 GLENS FALLS, NY 12801-3864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAXCEL WITH PASV PORT, MODEL 45-213 BOSTON SCIENTIFIC CORP. 510(k) NO: K032008(SPECIAL) ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 14-JUL-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONITECT OXYCODONE DRUG DCREEN CASSETTE TEST, MODEL MC 23, FASTE BRANAN MEDICAL CORP. 510(k) NO: K030113(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 02-JUL-03 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRODA MODEL 587 MANUAL WHEELCHAIR BRODA ENT., INC. 510(k) NO: K032133(TRADITIONAL) ATTN: PHILLIP MCTAGGART PHONE NO : 541 746 8080 385 PHILLIP ST. SE DECISION MADE: 21-JUL-03 WATERLOO ONTARIO, CANADA N2L 5R8 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY D C.R. BARD, INC. 510(k) NO: K030268(ABBREVIATED) ATTN: GLENN NORTON PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 30-JUL-03 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. 510(k) NO: K030442(TRADITIONAL) ATTN: RAMON RICART PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 21-JUL-03 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. BARD, INC. 510(k) NO: K031328(ABBREVIATED) ATTN: MARY J EDWARDS PHONE NO : 480-303-2640 1625 WEST 3RD ST. SE DECISION MADE: 25-JUL-03 TEMPE, AZ 85280 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-PROT DUO PORT C.R. BARD, INC. 510(k) NO: K032044(SPECIAL) ATTN: JOHN C KNORPP PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 10-JUL-03 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERHEART AED G3, MODEL 9300 CARDIAC SCIENCE 510(k) NO: K031987(SPECIAL) ATTN: KENNETH OLSON PHONE NO : 952-939-2912 5474 FELTL RD. SE DECISION MADE: 30-JUL-03 MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETY RELEASE ARCH BAR KIT CASEY SURGICAL, LLC 510(k) NO: K031207(TRADITIONAL) ATTN: JAMES E STANLEY PHONE NO : 816-347-9224 200 NE MULBERRY SE DECISION MADE: 15-JUL-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA LEE'S SUMMIT, MO 64086 DEVICE: CEFAR REHAB 2 AND REHAB 2 PRO CEFAR MEDICAL AB 510(k) NO: K030403(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763-571-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 17-JUL-03 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BA CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K031183(TRADITIONAL) ATTN: ROBERT M WOLFARTH PHONE NO : 512-432-9324 9900 SPECTRUM DR. SE DECISION MADE: 14-JUL-03 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH AL CLEAR MEDICAL, INC. 510(k) NO: K031416(TRADITIONAL) ATTN: LANE ABENROTH PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 15-JUL-03 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR CLINICAL DATA, INC. 510(k) NO: K031044(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-672-3553 1075 W. LAMBERT ROAD SE DECISION MADE: 15-JUL-03 BUILDING D 510(k) SUMMARY AVAILABLE FROM FDA BREA, CA 92821 DEVICE: BRAIN COIL, MODEL 9900GE-64 CLINICAL MR SOLUTIONS, LLC 510(k) NO: K031536(TRADITIONAL) ATTN: RALPH S HASHOIAN PHONE NO : 262-781-9394 3735 SHADYBROOK PLACE SE DECISION MADE: 18-JUL-03 BROOKFIELD, WI 53005 510(k) STATEMENT DEVICE: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS A CLINIQA CORPORATION 510(k) NO: K031575(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432 SOUTH MISSION RD. SE DECISION MADE: 23-JUL-03 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL 510(k) NO: K031623(SPECIAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 559 EAST WEDDELL DR. SE DECISION MADE: 03-JUL-03 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K031720(SPECIAL) ATTN: KEITH LOWREY PHONE NO : 805-685-3729 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 11-JUL-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K031956(SPECIAL) ATTN: KEITH LOWREY PHONE NO : 805-685-3729 130-B CREMONA DR. SE DECISION MADE: 17-JUL-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED INTEGRATED SYSTEMS NURSES ASSISTANT CONMED INTEGRATED SYSTEMS (CMIS) 510(k) NO: K031979(SPECIAL) ATTN: C. JEFF LIPPS PHONE NO : 503-614-1106 1815 NW 169TH PLACE SE DECISION MADE: 25-JUL-03 SUITE 4020 510(k) SUMMARY AVAILABLE FROM FDA BEAVERTON, OR 97006 DEVICE: FILMLESS CLINIC CONNECT IMAGING, INC. 510(k) NO: K031704(ABBREVIATED) ATTN: PHILIP J MANLY PHONE NO : 808-373-7048 850 WEST HIND DRIVE # 214 SE DECISION MADE: 31-JUL-03 HONOLULU, HI 96821 510(k) STATEMENT DEVICE: COOK GASTRIC SIZING BALLOON CATHETER COOK, INC. 510(k) NO: K030841(TRADITIONAL) ATTN: CAROL ZWISSLER PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 11-JUL-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: MODIFICATION TO COOK ZILVER BILIARY STENT COOK, INC. 510(k) NO: K031821(SPECIAL) ATTN: CAROL ZWISSLER PHONE NO : 812-339-2235 750 DANIELS WAY SE DECISION MADE: 18-JUL-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: CORIX 70 PLUS-USV CORAMEX, S.A. 510(k) NO: K031802(TRADITIONAL) ATTN: AL SOSA PHONE NO : 847-459-3889 251 E. DUNDEE ROAD SUITE #6 SE DECISION MADE: 21-JUL-03 WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIA CORDIS CORP. 510(k) NO: K031777(SPECIAL) ATTN: SAM MIRZA PHONE NO : 786-313-2007 14201 N.W. 60TH AVE. SE DECISION MADE: 07-JUL-03 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 CORGENIX, INC. 510(k) NO: K031208(SPECIAL) ATTN: NANCI DEXTER PHONE NO : 303-457-4345 12061 TEJON ST. SE DECISION MADE: 07-JUL-03 WESTMINSTER, CO 80234 510(k) STATEMENT DEVICE: CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1M CRYOMEDICAL INSTRUEMTS LTD. 510(k) NO: K031482(TRADITIONAL) ATTN: GARETH COPPING PHONE NO : 44 162 3424200 CRYOMED HOUSE, GROVE WAY SE DECISION MADE: 10-JUL-03 MANSFIELD WOODHOUSE, NOTTS, UNITED510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE PHOTOLIGHT PL CYNOSURE, INC. 510(k) NO: K031258(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 08-JUL-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) CYNOSURE, INC. 510(k) NO: K031690(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 08-JUL-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMIT II PLUS COCAINE METABOLITE ASSAY DADE BEHRING, INC. 510(k) NO: K031512(TRADITIONAL) ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551 P.O. BOX 6101 SE DECISION MADE: 23-JUL-03 NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANEL WITH NITROF DADE BEHRING, INC. 510(k) NO: K031602(TRADITIONAL) ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183 2040 ENTERPRISE BLVD. SE DECISION MADE: 31-JUL-03 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAINLESS STEEL AQUATIC WHEELCHAIR DB PERKS & ASSOCIATES LTD. 510(k) NO: K031910(TRADITIONAL) ATTN: ED OLIVER PHONE NO : 425-557-9990 490 NW DATEWOOD DRIVE SE DECISION MADE: 25-JUL-03 ISSAQUAH, WA 98027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLED CURING LIGHT SYSTEM DENTSPLY INTERNATIONAL 510(k) NO: K031615(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 21-JUL-03 YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTYLUS ELECTRIC MOTOR SYSTEM DENTSPLY INTL. 510(k) NO: K031145(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 15-JUL-03 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031203(TRADITIONAL) ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905 700 ORTHOPAEDIC DR. SE DECISION MADE: 14-JUL-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY CERAMIC FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031803(SPECIAL) ATTN: KARLA A HAM PHONE NO : 574-371-4925 700 ORTHOPAEDIC DR. SE DECISION MADE: 01-JUL-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031969(TRADITIONAL) ATTN: KATHY K TRIER PHONE NO : 574-372-5039 700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JUL-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DIADEXUS PLAC TEST DIADEXUS, INC. 510(k) NO: K030477(TRADITIONAL) ATTN: ROBERT L WOLFERT PHONE NO : 650-246-6400 343 OYSTER POINT BLVD. SE DECISION MADE: 18-JUL-03 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIF DIDECO S.P.A. 510(k) NO: K032040(SPECIAL) ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST ST. SE DECISION MADE: 09-JUL-03 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. 510(k) NO: K031400(SPECIAL) ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 15-JUL-03 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SITE-RITE IV ULTRASOUND SYSTEM DYMAX CORP. 510(k) NO: K032135(TRADITIONAL) ATTN: CHARLES MORREALE PHONE NO : 412-963-6884 271 KAPPA DR. SE DECISION MADE: 21-JUL-03 PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EARLYDETECT MENOPAUSE TEST FOR FSH EARLY DETECT, INC. 510(k) NO: K030058(TRADITIONAL) ATTN: PETER GEORGE PHONE NO : 714-283-5190 2950 NORTH GLASSELL ST. SE DECISION MADE: 30-JUL-03 ORANGE, CA 92865 510(k) STATEMENT DEVICE: EBI XFIX OPTIROM KNEE FIXATOR EBI, L.P. 510(k) NO: K031093(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 10-JUL-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI SPINELINK - II SPINAL FIXATION SYSTEM EBI, L.P. 510(k) NO: K031355(TRADITIONAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 22-JUL-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI SPINELINK SPINAL FIXATION SYSTEM EBI, L.P. 510(k) NO: K031424(TRADITIONAL) ATTN: BARRY SANDS PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 22-JUL-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEROLET TOILET LIFT, MODEL AER-01 ECONOMIC HOLLAND B.V. 510(k) NO: K031045(TRADITIONAL) ATTN: STEPHANIE WOLFKAMP PHONE NO : 336-766-7686 6785 FOREST OAK DR. SE DECISION MADE: 10-JUL-03 CLEMMONS, NC 27012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT EDWARDS LIFESCIENCES, LLC. 510(k) NO: K024303(TRADITIONAL) ATTN: KAVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 03-JUL-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. 510(k) NO: K030637(TRADITIONAL) ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 22-JUL-03 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION ELECTROMED IMAGING INC. 510(k) NO: K031638(ABBREVIATED) ATTN: WARREN BAKER PHONE NO : 450 681 3925 440 ARMAND-FRAPPIER BLVD.,#250 SE DECISION MADE: 21-JUL-03 LAVAL, QUEBEC, CANADA H7V 4B4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROMEDICARIN 900 ELECTROMEDICARIN, S.A. 510(k) NO: K020478(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 17-JUL-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM ELEKTA INSTRUMENT AB 510(k) NO: K031980(SPECIAL) ATTN: PETER LOWENDAHL PHONE NO : 46 8 58725400 BIRGER JARLSGATAN 53 SE DECISION MADE: 25-JUL-03 PO BOX 7593 510(k) STATEMENT STOCKHOLM, SWEDEN SE-103 93 DEVICE: ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT ELEKTA INSTRUMENT AB 510(k) NO: K031999(SPECIAL) ATTN: PETER LOWENDAHL PHONE NO : 46 8 58725400 BIRGER JARLSGATAN 53 SE DECISION MADE: 25-JUL-03 STOCKHOLM, SWEDEN S-103 93 510(k) STATEMENT DEVICE: CARDIOVATIONS OPTICAL BIPOLAR DEVICE ETHICON, INC. 510(k) NO: K031846(SPECIAL) ATTN: PETER CECCHINI PHONE NO : 908-218-2457 ROUTE 22 WEST SE DECISION MADE: 21-JUL-03 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOVATIONS RETRACTOR ETHICON, INC. 510(k) NO: K031847(SPECIAL) ATTN: PETER CECCHINI PHONE NO : 908-218-2457 ROUTE 22 WEST SE DECISION MADE: 21-JUL-03 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORDEX POWER TRACTION EQUIPMENT EVER PROSPEROUS INSTRUMENT INC 510(k) NO: K031227(TRADITIONAL) ATTN: JOHN BOREN PHONE NO : 281-398-1700 15915 KATY FREEWAY SE DECISION MADE: 17-JUL-03 SUITE 645 510(k) STATEMENT HOUSTON, TX 77094 DEVICE: EXCEL PRIMARY SOLUTION SET EXELINT INTL. CO. 510(k) NO: K031500(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 WEST CENTINELA AVE. SE DECISION MADE: 25-JUL-03 LOS ANGELES, CA 90045 510(k) STATEMENT DEVICE: FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS FIRST QUALITY HYGIENIC, INC. 510(k) NO: K031067(TRADITIONAL) ATTN: ROBERT J STAAB PHONE NO : 201-327-0035 73 FRANKLIN TURNPIKE SE DECISION MADE: 14-JUL-03 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRATORY HUMIDIFIER, MODEL MR850 FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K020332(TRADITIONAL) ATTN: BRETT WHISTON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 07-JUL-03 EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURALASE LP ND:YAG LASER FOCUS MEDICAL, LLC. 510(k) NO: K031828(TRADITIONAL) ATTN: JOHN LEE, JR PHONE NO : 203-730-8885 23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 17-JUL-03 BETHEL, CT 06801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM FOTONA D.D. 510(k) NO: K024204(TRADITIONAL) ATTN: MOJCA VALJAVEC PHONE NO : 386 1 5009114 STEGNE 7, SE DECISION MADE: 07-JUL-03 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALT MEDICAL GUIDEWIRE GALT MEDICAL CORP. 510(k) NO: K031916(SPECIAL) ATTN: DAVID CATLIN PHONE NO : 972-271-5177 2475 MERRITT DR. SE DECISION MADE: 17-JUL-03 GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DPX SERIES BRAVO DUO BONE DENSITOMETER GE LUNAR CORP. 510(k) NO: K030962(TRADITIONAL) ATTN: JAMES P RASKOB PHONE NO : 608-826-7425 726 HEARTLAND TRAIL SE DECISION MADE: 25-JUL-03 MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DELTA SOFTWARE OPTION FOR MRI GE MEDICAL SYSTEMS 510(k) NO: K031927(TRADITIONAL) ATTN: LARRY KREGER PHONE NO : 262-544-3464 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 02-JUL-03 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS 510(k) NO: K032045(SPECIAL) ATTN: LARRY KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 30-JUL-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K031376(SPECIAL) ATTN: MELISSA ROBINSON PHONE NO : 817-887-2133 4502 WOODLAND CORP.BLVD. SE DECISION MADE: 16-JUL-03 TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER CO. 510(k) NO: K031036(TRADITIONAL) ATTN: AMY J PAUKOVITS PHONE NO : 216-271-5252 9410 ST. CATHERINE AVE. SE DECISION MADE: 10-JUL-03 CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ 7, MODEL 2354858 GENERAL ELECTRIC CO. 510(k) NO: K032182(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 25-JUL-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUS GENZYME BIOSURGERY 510(k) NO: K031554(TRADITIONAL) ATTN: DENISE LIMA PHONE NO : 508-677-6439 600 AIRPORT RD. SE DECISION MADE: 25-JUL-03 FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR GETINGE USA, INC 510(k) NO: K031647(TRADITIONAL) ATTN: KARLA BYRNE PHONE NO : 585-272-5007 1777 EAST HENRIETTA RD. SE DECISION MADE: 29-JUL-03 ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. 510(k) NO: K031033(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 490 97784 NEW INDUSTRIAL PARK SE DECISION MADE: 01-JUL-03 P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA YOQNEAM, ISRAEL 20692 DEVICE: NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE GREEN PROSPECT SDN BHD 510(k) NO: K031580(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 25-JUL-03 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATE GREEN PROSPECT SDN BHD 510(k) NO: K031581(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 24-JUL-03 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE GUARDIAN ANGEL PRODUCTS, INC. 510(k) NO: K030547(SPECIAL) ATTN: ERNEST H PESCATORE PHONE NO : 215-938-7677 2771 PHILMONT AVE. SE DECISION MADE: 11-JUL-03 HUNTINGDON VALLEY, PA 19006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDO CUT-AWAY CUTTER GUIDANT CORP. 510(k) NO: K031459(TRADITIONAL) ATTN: SHAH HILALI PHONE NO : 651-582-7752 4100 HAMLINE AVE., NORTH SE DECISION MADE: 23-JUL-03 ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE GUIDANT CORPORATION 510(k) NO: K031688(SPECIAL) ATTN: STEPHANIE ISGRIGG ROBINSON PHONE NO : 651-582-4927 4100 HAMLINE AVE NORTH SE DECISION MADE: 02-JUL-03 ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) GYRUS MEDICAL, INC. 510(k) NO: K031085(TRADITIONAL) ATTN: MERCEDES BAYANI PHONE NO : 763-416-3015 6655 WEDGWOOD RD. SE DECISION MADE: 21-JUL-03 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA MAPLE GROVE, MN 55311-3602 DEVICE: HL168R HEALTH & LIFE CO., LTD. 510(k) NO: K031695(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 01-JUL-03 CHUNG HO CITY, TAIPEI, HSIEN, CHIN510(k) STATEMENT DEVICE: HL888RA HEALTH & LIFE CO., LTD. 510(k) NO: K031835(SPECIAL) ATTN: SUSAN CHEN PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 01-JUL-03 CHUNG HO CITY, TAIPEI, HSIEN, CHIN510(k) STATEMENT DEVICE: SUILE WOUND DRESSING HEDONIST BIOCHEMICAL TECHNOLOGIES 510(k) NO: K022967(TRADITIONAL) ATTN: ERIC LUO PHONE NO : 972-491-2059 6833 SAINT LAWRENCE ST. SE DECISION MADE: 08-JUL-03 PLANO, TX 75024 510(k) STATEMENT DEVICE: HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVE HOFFRICHTER GMBH 510(k) NO: K014074(TRADITIONAL) ATTN: STEPHEN H GORSKI PHONE NO : 262-594-2114 S65 W35739 PIPER RD. SE DECISION MADE: 23-JUL-03 EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART HOME DIAGNOSTICS, INC. 510(k) NO: K030703(TRADITIONAL) ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201 2400 N.W. 55TH CT. SE DECISION MADE: 11-JUL-03 FORT LAUDERDALE, FL 33309 510(k) STATEMENT DEVICE: LIFEVALVE CENTRAL VENOUS CATHTER HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K031718(SPECIAL) ATTN: SCOTT MOELLER PHONE NO : 800-472-5221 1 HORIZON WAY SE DECISION MADE: 02-JUL-03 MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPO HOWMEDICA OSTEONICS CORP. 510(k) NO: K031480(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SOUTH SE DECISION MADE: 31-JUL-03 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K031893(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 17-JUL-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMANN II COMPACT BALTIMORE COUPLING HOWMEDICA OSTEONICS CORP. 510(k) NO: K031941(SPECIAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 59 ROUTE 17 SE DECISION MADE: 24-JUL-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER PLATING SYSTEM PERIARTICULAR PLATES HOWMEDICA OSTEONICS CORP. 510(k) NO: K031959(SPECIAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 59 ROUTE 17 SOUTH SE DECISION MADE: 25-JUL-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 780 HUDSON RESPIRATORY CARE, INC. 510(k) NO: K031383(SPECIAL) ATTN: CHARLES MIERKIEWICZ PHONE NO : 909-676-5611 27711 DIAZ RD. SE DECISION MADE: 07-JUL-03 P.O. BOX 9020 510(k) SUMMARY AVAILABLE FROM FDA TEMECULA, CA 92589-9020 DEVICE: ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS ICS MEDICAL 510(k) NO: K031986(SPECIAL) ATTN: DELMAR F BLOEM PHONE NO : 800-289-2150 125 COMMERCE DR. SE DECISION MADE: 24-JUL-03 SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS IMAGE ANALYSIS, INC. 510(k) NO: K031991(SPECIAL) ATTN: BEN ARNOLD PHONE NO : 270-384-6400 1380 BURKESVILLE ST. SE DECISION MADE: 30-JUL-03 COLUMBIA, KY 42728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBELLACOL IMMUNOSTICS, INC. 510(k) NO: K031490(TRADITIONAL) ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770 3505 SUNSET AVE. SE DECISION MADE: 16-JUL-03 OCEAN, NJ 07712 510(k) STATEMENT DEVICE: OSSEOTITE NT CERTAIN IMPLANTS IMPLANT INNOVATIONS, INC. 510(k) NO: K031475(TRADITIONAL) ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819 4555 RIVERSIDE DR. SE DECISION MADE: 28-JUL-03 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 IMPLEX CORP. 510(k) NO: K031823(SPECIAL) ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 11-JUL-03 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL FACTOR IX DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. 510(k) NO: K031829(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 526 RT. 303 SE DECISION MADE: 31-JUL-03 ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTION JET AJ-4270 URINE ANALYZER INTERNATIONAL REMOTE IMAGING SYSTE510(k) NO: K030600(TRADITIONAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 11-JUL-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K031417(TRADITIONAL) ATTN: PAMELA MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 11-JUL-03 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC INTRAVASCULAR INCORPORATED 510(k) NO: K031783(SPECIAL) ATTN: STEVE APERAVICH PHONE NO : 847-596-7700 3600 BUR WOOD DR. SE DECISION MADE: 01-JUL-03 WAUKEGAN, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RH-900 IOMED, INC. 510(k) NO: K031115(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801-975-1191 2441 SOUTH 3850 WEST, SUITE A SE DECISION MADE: 10-JUL-03 SALT LAKE CITY, UT 84120-9941 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 IVD RESEARCH, INC. 510(k) NO: K031059(TRADITIONAL) ATTN: DAVE LAMBILLOTTE PHONE NO : 760-929-7744 5909 SEA LION PLACE, SUITE D SE DECISION MADE: 10-JUL-03 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II JASON MARINE ENTERPRISES, INC. 510(k) NO: K031342(ABBREVIATED) ATTN: BRIAN GAGNON PHONE NO : 888-773-3537 4311 N.W. 64TH AVE. SE DECISION MADE: 10-JUL-03 CORAL SPRINGS, FL 33067 510(k) STATEMENT DEVICE: JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PL JMS NORTH AMERICA CORP. 510(k) NO: K023668(TRADITIONAL) ATTN: SWEE CHEAU CHONG PHONE NO : 510-888-9090 22320 FOOTHILL BLVD., SE DECISION MADE: 01-JUL-03 SUITE 350 510(k) STATEMENT HAYWARD, CA 94541 DEVICE: TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 KALACO SCIENTIFIC, INC. 510(k) NO: K024377(TRADITIONAL) ATTN: GRACE BARTOO PHONE NO : 650-654-4484 131 GLENN WAY SE DECISION MADE: 21-JUL-03 SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA SAN CARLOS, CA 94070 DEVICE: PROPHYPEARLS KAVO AMERICA 510(k) NO: K031868(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 09-JUL-03 DEER FIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 KAVO AMERICA 510(k) NO: K032081(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 24-JUL-03 DEER FIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAND OUT KERR CORP. 510(k) NO: K031484(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 716-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 03-JUL-03 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIBOND FL KERR DENTAL MATERIALS CENTER 510(k) NO: K031444(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 02-JUL-03 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX KOVEN TECHNOLOGY, INC. 510(k) NO: K031504(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 18-JUL-03 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 KUANN DAH INDUSTRY CO., LTD. 510(k) NO: K031309(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 31-JUL-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. 510(k) NO: K031060(TRADITIONAL) ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-335-5288 234 LIBBEY PKWY. SE DECISION MADE: 11-JUL-03 WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBC PRESS ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. 510(k) NO: K031250(TRADITIONAL) ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1637 234 LIBBEY PKWY. SE DECISION MADE: 15-JUL-03 WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 LINVATEC BIOMATERIALS, LTD. 510(k) NO: K031981(SPECIAL) ATTN: LAURA KREJCI PHONE NO : 727-399-5234 1311 CONCEPT BLVD SE DECISION MADE: 25-JUL-03 LARGO, FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES LUMENIS, LTD. 510(k) NO: K030033(TRADITIONAL) ATTN: ANNE WORDEN PHONE NO : 925-895-1200 2400 CONDENSA ST. SE DECISION MADE: 21-JUL-03 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS LUMENIS, LTD. 510(k) NO: K030342(TRADITIONAL) ATTN: ANDREA L RUTH PHONE NO : 408-764-3235 2400 CONDENSA ST. SE DECISION MADE: 17-JUL-03 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACROPORE OS RECONSTRUCTION MACROPORE BIOSURGERY, INC. 510(k) NO: K024169(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900 6740 TOP GUN ST. SE DECISION MADE: 01-JUL-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAINLINE MAXIE HCG URINE PREGNANCY TEST MAINLINE TECHNOLOGY, INC. 510(k) NO: K031445(TRADITIONAL) ATTN: MARTHA MAZUREK PHONE NO : 734-930-2043 3985 RESEARCH PARK DR. SE DECISION MADE: 01-JUL-03 ANN ARBOR, MI 48108 510(k) STATEMENT DEVICE: OPTIBOLUS MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K031339(SPECIAL) ATTN: ELLIS ROGERS PHONE NO : 513-948-4041 2111 EAST GALBRAITH RD. SE DECISION MADE: 11-JUL-03 CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND D MAXXVISION, LLC 510(k) NO: K031372(TRADITIONAL) ATTN: JAMES K WALKER PHONE NO : 352-378-6620 3014 NE 21ST WAY SE DECISION MADE: 02-JUL-03 GAINESVILLE, FL 32609 510(k) STATEMENT DEVICE: MAYO CLINIC BC-10 1.5T MAYO MEDICAL VENTURES 510(k) NO: K031119(ABBREVIATED) ATTN: JADE SADOSTY PHONE NO : 507-284-8878 200 FIRST ST SW SE DECISION MADE: 15-JUL-03 ROCHESTER, MN 55905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031392(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 01-JUL-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: URICHEMTRAK LIQUID ASSAYED URINE CONTROL MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031441(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 01-JUL-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031890(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 16-JUL-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: NGT MEDICAL INNOVATIVE PRODUCTS 510(k) NO: K022558(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 08-JUL-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIX2VIAL TRANSFER DEVICE MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K031861(TRADITIONAL) ATTN: BENNY ARAZY PHONE NO : 972 499 40337 MITZPE AVIV, INDUSTRIAL PK 13 SE DECISION MADE: 29-JUL-03 M.P. MISGAV, ISRAEL 20187 510(k) STATEMENT DEVICE: SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMEN MEDISISS 510(k) NO: K030919(TRADITIONAL) ATTN: MRRY ANN BARKER PHONE NO : 541-549-4164 723 CURTIS COURT SE DECISION MADE: 03-JUL-03 PO BOX 2060 510(k) SUMMARY AVAILABLE FROM FDA SISTERS, OR 97759 THIRD PARTY REVIEW DEVICE: MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC. 510(k) NO: K031843(SPECIAL) ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759 ONE MEDLINE PL. SE DECISION MADE: 03-JUL-03 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MEDRAD SWABBABLE VALVE TRANSFER SET MEDRAD, INC. 510(k) NO: K031808(SPECIAL) ATTN: ANDREW P ZELTWANGER PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 11-JUL-03 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERDICT II, PROFILE II MEDTOX DIAGNOSTICS, INC. 510(k) NO: K031032(SPECIAL) ATTN: ALAN MORRIS PHONE NO : 336-226-6311 1238 ANTHONY RD. SE DECISION MADE: 14-JUL-03 BURLINGTON, NC 27215 510(k) STATEMENT DEVICE: MC2X MULTI-STAGE VENOUS CANNULA MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K031776(SPECIAL) ATTN: RONALD W BENNETT PHONE NO : 763-391-9086 7611 NORTHLAND DR. SE DECISION MADE: 25-JUL-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K031827(SPECIAL) ATTN: PREETI JAIN PHONE NO : 763-391-9000 7611 NORTHLAND DR. SE DECISION MADE: 02-JUL-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K031780(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 30-JUL-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MED MEDTRONIC, INC. 510(k) NO: K030671(TRADITIONAL) ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 37A CHERRY HILL DR. SE DECISION MADE: 31-JUL-03 DANVERS, MA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH MEDTRONIC, INC. 510(k) NO: K031211(TRADITIONAL) ATTN: LYNN JENSEN PHONE NO : 763-514-4459 7000 CENTRAL AVENUE NE SE DECISION MADE: 17-JUL-03 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM MEDTRONIC, INC. 510(k) NO: K031247(TRADITIONAL) ATTN: SCOTT CUNDY PHONE NO : 763-391-9941 7601 NORTHLAND DR. SE DECISION MADE: 17-JUL-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGATECH SCIENTIFIC FACE MASK MEGATECH SCIENTIFIC PTE LTD 510(k) NO: K030239(TRADITIONAL) ATTN: CHIAM KIA CHEE PHONE NO : 65 656 57211 BLK 2 BUKIT BATOK STREET 24 SE DECISION MADE: 24-JUL-03 SKYTECH #09-03, SINGAPORE 659480 510(k) STATEMENT DEVICE: MENTOR OBTAPE TRANS-OBTURATOR TAPE MENTOR CORP. 510(k) NO: K031767(TRADITIONAL) ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DR. SE DECISION MADE: 17-JUL-03 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 MERCURY MEDICAL 510(k) NO: K031411(TRADITIONAL) ATTN: WAYNE GLOVER PHONE NO : 800-237-6418 11300 49TH ST. NORTH SE DECISION MADE: 30-JUL-03 CLEARWATER, FL 33762-4800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. 510(k) NO: K030392(TRADITIONAL) ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 21-JUL-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCW PERCUTANEOUS COMPRESSION WIRE MILLENNIUM MEDICAL TECHNOLOGIES, I510(k) NO: K031050(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LN. SE DECISION MADE: 14-JUL-03 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 MINIMED, INC. 510(k) NO: K031390(TRADITIONAL) ATTN: MIRIELLE MENGOTTO PHONE NO : 818-362-5958 18000 DEVONSHIRE ST. SE DECISION MADE: 23-JUL-03 NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODEL MOGUL ENTERPRISES 510(k) NO: K030852(SPECIAL) ATTN: JAMIL MOGUL PHONE NO : 408-629-3340 6387 SAN IGNACIO AVE. SE DECISION MADE: 10-JUL-03 SAN JOSE, CA 95119 510(k) STATEMENT DEVICE: ELI 200+ AUDICOR MORTARA INSTRUMENT, INC. 510(k) NO: K031182(TRADITIONAL) ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600 7865 NORTH 86TH ST. SE DECISION MADE: 25-JUL-03 MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODEL J-5 MVO-MONITOR MYOTRONICS-NOROMED, INC. 510(k) NO: K031998(SPECIAL) ATTN: FRAY ADIB PHONE NO : 206-243-4214 15425 53RD AVE. SOUTH SE DECISION MADE: 24-JUL-03 TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR MYTECH TECHNOLOGY CO., LTD. 510(k) NO: K030221(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-JUL-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 400 NEEDLETECH PRODUCTS, INC. 510(k) NO: K031173(TRADITIONAL) ATTN: RICK TRIPP PHONE NO : 508-431-4000 81 WEST ST. SE DECISION MADE: 23-JUL-03 ATTLEBORO, MA 02703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K032188(TRADITIONAL) ATTN: JIMMY WONG PHONE NO : 949-940-7260 1311 CALLE BATIDO SE DECISION MADE: 31-JUL-03 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARBON FIBER BRIDGE, MODEL 28757 NOBEL BIOCARE AB 510(k) NO: K031070(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22725 SAVI RANCH PKWY. SE DECISION MADE: 03-JUL-03 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTHETIC ZIRCONIA ABUTMENT NOBEL BIOCARE AB 510(k) NO: K031719(SPECIAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 02-JUL-03 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBEL DIRECT, MODELS 30937, 30938 NOBEL BIOCARE USA, INC. 510(k) NO: K031345(TRADITIONAL) ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 24-JUL-03 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 9600, AVANT PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K023044(TRADITIONAL) ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166 2605 FERNBROOK LN. NORTH SE DECISION MADE: 23-JUL-03 PLYMOUTH, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVIDENCE MOLDING HELMET NORTHEAST ORTHOTICS AND PROTHETICS510(k) NO: K030669(ABBREVIATED) ATTN: D. BARRY MCCOY PHONE NO : 401-444-5477 170 MACKLIN STREET SE DECISION MADE: 18-JUL-03 CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. 510(k) NO: K030470(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST. SE DECISION MADE: 07-JUL-03 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843 THIRD PARTY REVIEW DEVICE: HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) C OCULAR SCIENCES, INC. 510(k) NO: K031477(ABBREVIATED) ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE RD, SUITE 30 SE DECISION MADE: 18-JUL-03 ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V OLYMPUS OPTICAL CO., LTD. 510(k) NO: K031648(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 TWO CORPORATE CENTER DR. SE DECISION MADE: 24-JUL-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE OLYMPUS OPTICAL CO., LTD. 510(k) NO: K032092(TRADITIONAL) ATTN: MASAO WADA PHONE NO : 814 264 22891 34-3 HIRAI HINODE-MACHI, SE DECISION MADE: 16-JUL-03 NISHITAMA-GUN, TOKYO, JAPAN 190-01510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE OLYMPUS OPTO-ELECTRONICS CO., LTD.510(k) NO: K031256(TRADITIONAL) ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477 TWO CORPORATE CENTER DR. SE DECISION MADE: 23-JUL-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 OPUS MEDICAL, INC. 510(k) NO: K030170(TRADITIONAL) ATTN: JAMES W HART PHONE NO : 949-234-0400 27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 28-JUL-03 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) ORGAN RECOVERY SYSTEMS, INC. 510(k) NO: K021362(TRADITIONAL) ATTN: STANLEY J HARRIS PHONE NO : 843-722-6657 701 EAST BAY ST. SE DECISION MADE: 31-JUL-03 SUITE 433 510(k) STATEMENT CHARLESTON, SC 29403 DEVICE: ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM ORTHO DEVELOPMENT CORP. 510(k) NO: K031201(TRADITIONAL) ATTN: NADEEM AHMED PHONE NO : 801-553-9991 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 15-JUL-03 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTENDERS BGS GRANULES, CUBES, BLOCKS, AND PLUGS OSTEOBIOLOGICS, INC. 510(k) NO: K030288(TRADITIONAL) ATTN: GABRIELE G NEIDERAUER PHONE NO : 210-690-2131 UNIVERSITY BUSINESS PARK SE DECISION MADE: 17-JUL-03 12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA SAN ANTONIO, TX 78249-3308 DEVICE: TEMPORARY RESIN CEMENT PARKELL, INC. 510(k) NO: K031212(TRADITIONAL) ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134 155 SCHMITT BLVD. SE DECISION MADE: 11-JUL-03 P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA FARMINGDALE, NY 11735 DEVICE: PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN PASCO LABORATORIES, INC. 510(k) NO: K031727(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-390-3240 12750 WEST 42ND AVE. SE DECISION MADE: 30-JUL-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHOCKWAVE SUSPENSION WHEELCHAIR PER4MAX MEDICAL, LLC 510(k) NO: K032123(TRADITIONAL) ATTN: TIM CRISWELL PHONE NO : 972-641-6773 2550 114TH ST., SUITE 190 SE DECISION MADE: 31-JUL-03 GRAND PRAIRIE, TX 75050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECQUIRE CELL SEPARATOR PERFUSION PARTNERS & ASSOC. INC. 510(k) NO: K024080(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888-729-9674 P.O. BOX 4341 SE DECISION MADE: 02-JUL-03 CROFTON, MD 21114 510(k) STATEMENT DEVICE: PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE PHILIPS MEDICAL SYSTEMS 510(k) NO: K030939(SPECIAL) ATTN: JUDITH K PHILLIPS PHONE NO : 412-279-3263 1082 BOWER HILL RD. SE DECISION MADE: 15-JUL-03 PITTSBURGH, PA 15243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICOSAT II SPO2 PULSE OXIMETRY MODULE PHILIPS MEDICAL SYSTEMS 510(k) NO: K030973(SPECIAL) ATTN: DAVID OSBORN PHONE NO : 978-659-3178 3000 MINUTEMAN RD. SE DECISION MADE: 23-JUL-03 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III PHILIPS MEDICAL SYSTEMS 510(k) NO: K031422(ABBREVIATED) ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319 3000 MINUTEMAN RD. SE DECISION MADE: 03-JUL-03 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHILIPS VIEWFORUM 2003 PHILIPS MEDICAL SYSTEMS 510(k) NO: K032096(TRADITIONAL) ATTN: LYNN T HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY SE DECISION MADE: 18-JUL-03 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-8431 THIRD PARTY REVIEW DEVICE: PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M51 PHILIPS MEDICAL SYSTEMS 510(k) NO: K032103(SPECIAL) ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319 3000 MINUTEMAN RD. SE DECISION MADE: 22-JUL-03 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUNLEE "FORMAT" COLLIMATOR FAMILY PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K031597(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 21-JUL-03 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 DEVICE: PHILLIPS OMNIDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K032046(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 17-JUL-03 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 THIRD PARTY REVIEW DEVICE: GEMINI 16 PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K032036(TRADITIONAL) ATTN: CHRISTOF LITTWITZ PHONE NO : 440-483-3585 595 MINER RD. SE DECISION MADE: 11-JUL-03 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMNILUX RED PHOTO THERAPEUTICS LIMITED 510(k) NO: K030426(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LN. SE DECISION MADE: 17-JUL-03 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UC-PLUS SOLUTION UNICONDYLAR KNEE PLUS ORTHOPEDICS 510(k) NO: K032052(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 25-JUL-03 ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER PNEU PAC, LTD. 510(k) NO: K021841(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100 SMITHS MEDICAL SE DECISION MADE: 17-JUL-03 N7 W22025 JOHNSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53186-1856 DEVICE: PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT PORTEX, INC. 510(k) NO: K031057(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 18-JUL-03 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE PT. WRP BUANA MULTICORPORA 510(k) NO: K032007(TRADITIONAL) ATTN: NG POY SIN PHONE NO : 061 694 2461 JALAN JERMAL #20B, KELURAHAN SE DECISION MADE: 28-JUL-03 SEI MATI, MEDAN LABUHAN KM 17 510(k) SUMMARY AVAILABLE FROM FDA MEDAN, INDONESIA 20252 DEVICE: FASTPACK FREE T4 IMMUNOASSAY QUALIGEN, INC. 510(k) NO: K030329(TRADITIONAL) ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165 2042 CORTE DEL NOGAL SE DECISION MADE: 03-JUL-03 CARLSBAD, CA 92009-1410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIUS 018 COUGAR WIRE RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K032129(SPECIAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY TRAIL SE DECISION MADE: 17-JUL-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPECT INFLUENZA A/B REMEL INC 510(k) NO: K031565(TRADITIONAL) ATTN: MARY ANN SILVIUS PHONE NO : 913-895-4054 12076 SANTA FE DRIVE SE DECISION MADE: 17-JUL-03 LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK RESMED LTD. 510(k) NO: K024191(TRADITIONAL) ATTN: ROGER KOTTER PHONE NO : 858-746-2282 14040 DANIELSON ST. SE DECISION MADE: 02-JUL-03 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP HARMONY VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. 510(k) NO: K031656(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 30-JUL-03 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E RITA MEDICAL SYSTEMS INC 510(k) NO: K031926(SPECIAL) ATTN: ERIN MAZZONE PHONE NO : 650-314-3400 967 N. SHORELINE BLVD. SE DECISION MADE: 17-JUL-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERRITIN GENERATION 2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K031650(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 17-JUL-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK COMPACT TEST STRIP ROCHE DIAGNOSTICS CORP. 510(k) NO: K031755(SPECIAL) ATTN: SCOTT THIEL PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 03-JUL-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA CHOLESTEROL GEN. 2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K031824(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 09-JUL-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA CARBON DIOXIDE ASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K031879(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 17-JUL-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL ROCHE DIAGNOSTICS CORP. 510(k) NO: K031880(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 16-JUL-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC ROCHE DIAGNOSTICS CORP. 510(k) NO: K032089(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 30-JUL-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR FIBER OPTIC ECG GATING SYSTEM SA INSTRUMENTS, INC. 510(k) NO: K031731(TRADITIONAL) ATTN: G. RONALD MORRIS PHONE NO : 631-689-9804 65 MAIN STREET SE DECISION MADE: 30-JUL-03 STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAUFLON MULTIPURPOSE SOLUTION - NO RUB SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K030278(TRADITIONAL) ATTN: LIGIA DELACRUZ PHONE NO : 44 208 3224200 49-53 YORK ST. SE DECISION MADE: 30-JUL-03 TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, SCANTIBODIES LABORATORY, INC. 510(k) NO: K031534(TRADITIONAL) ATTN: RICHARD LENART PHONE NO : 619-258-9300 9336 ABRAHAM WAY SE DECISION MADE: 30-JUL-03 SANTEE, CA 92071 510(k) STATEMENT DEVICE: UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS SEASPINE 510(k) NO: K031381(TRADITIONAL) ATTN: DIANA SMITH PHONE NO : 619-251-9132 727 PARK BLVD. SE DECISION MADE: 30-JUL-03 SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEZ SAFETY SYRINGE SEZ CORPORATION 510(k) NO: K031163(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO 7007 SE DECISION MADE: 08-JUL-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL EXAM GLOVES, POWDER-FREE, YELLOW SHANGHAI JIAWANG INDUSTRIAL CO. LT510(k) NO: K031854(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 25-JUL-03 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: GLASIONOMER FX-II SHOFU DENTAL CORP. 510(k) NO: K031467(TRADITIONAL) ATTN: ROBERT NOBLE PHONE NO : 760-736-3277 1225 STONE DR. SE DECISION MADE: 17-JUL-03 SAN MARCOS, CA 92069-4059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON CV70 CARDIOVASCULAR SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032111(TRADITIONAL) ATTN: CAREY CHAVEZ PHONE NO : 425-557-1683 22010 S.E. 51ST ST. SE DECISION MADE: 18-JUL-03 ISSAQUAH, WA 98029-7298 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K032114(TRADITIONAL) ATTN: JERRY W TSUTSUMI PHONE NO : 650-943-7286 1230 SHOREBIRD WAY SE DECISION MADE: 21-JUL-03 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW DEVICE: PEEK TETRIS SPINAL IMPLANT SIGNUS MEDICAL LLC. 510(k) NO: K031757(SPECIAL) ATTN: AL ALEXANDER PHONE NO : 763-287-3830 4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 30-JUL-03 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: SINCLAIR WOUND AND SKIN EMULSION SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K024367(TRADITIONAL) ATTN: MICHAEL KILLEEN PHONE NO : 441 483 428611 BOROUGH RD. SE DECISION MADE: 28-JUL-03 GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXINIUM FEMORAL HEADS SMITH & NEPHEW, INC. 510(k) NO: K030766(SPECIAL) ATTN: KIM P KELLY PHONE NO : 901-399-6566 1450 E. BROOKS RD. SE DECISION MADE: 25-JUL-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTERNAL FIXATION SYSTEMS SMITH & NEPHEW, INC. 510(k) NO: K031181(TRADITIONAL) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS RD. SE DECISION MADE: 14-JUL-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 SMITH & NEPHEW, INC. 510(k) NO: K031685(SPECIAL) ATTN: JASON BILOBRAM PHONE NO : 508-261-3699 130 FORBES BLVD. SE DECISION MADE: 01-JUL-03 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANLUBE SONOTECH, INC. 510(k) NO: K031222(TRADITIONAL) ATTN: MARGARET J LARSON PHONE NO : 360-671-9121 774 MARINE DR. SE DECISION MADE: 23-JUL-03 BELLINGHAM, WA 98225 510(k) STATEMENT DEVICE: SCANTEC PAD SONOTECH, INC. 510(k) NO: K031894(SPECIAL) ATTN: MARGARET J LARSON PHONE NO : 360-671-9121 774 MARINE DR. SE DECISION MADE: 18-JUL-03 BELLINGHAM, WA 98225 510(k) STATEMENT DEVICE: BENCO SPHERICAL SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K031658(TRADITIONAL) ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300 729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 29-JUL-03 BENSENVILLE, IL 60106 510(k) STATEMENT DEVICE: SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K030087(ABBREVIATED) ATTN: LISA PETERSON PHONE NO : 512-918-2700 5301 RIATA PARK COURT SE DECISION MADE: 17-JUL-03 BLDG F 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78727 DEVICE: MODIFICATION TO FORTITUDE CEMENT RESTRICTOR SPINAL CONCEPTS, INC. 510(k) NO: K031837(SPECIAL) ATTN: LISA PETERSON PHONE NO : 512-533-1080 5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 24-JUL-03 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORLON NONABSORABLE SURGICAL SUTURE USP SRI ORION PHARMACEUTICALS & SUTURE510(k) NO: K030177(ABBREVIATED) ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DR. SE DECISION MADE: 21-JUL-03 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEEL CS CATHETER DELIVERY SYSTEM ST. JUDE MEDICAL 510(k) NO: K031906(SPECIAL) ATTN: MIKE BURNSIDE PHONE NO : 952-933-4700 14901 DEVEAU PL. SE DECISION MADE: 18-JUL-03 MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) STELLARTECH RESEARCH CORP. 510(k) NO: K032062(SPECIAL) ATTN: JAMES R SANTOS PHONE NO : 408-331-3000 1346 BORDEAUX DR. SE DECISION MADE: 29-JUL-03 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI DENTAL IMPLANT SYSTEM STRAUMANN USA 510(k) NO: K031055(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 781-890-0001 RESERVOIR PLACE, SE DECISION MADE: 07-JUL-03 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02154 DEVICE: THE SUAD DEVICE STRONG DENTAL INC. 510(k) NO: K023836(ABBREVIATED) ATTN: CLYDE A TAKEGUCHI PHONE NO : 703-406-0906 21525 RIDGETOP CIRCLE SE DECISION MADE: 08-JUL-03 SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA STERLING, VA 20166 DEVICE: MODIFICATION TO STRYKER PAINPUMP STRYKER INSTRUMENTS 510(k) NO: K031249(TRADITIONAL) ATTN: NICOLE PETTY PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 21-JUL-03 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L SUNDER BIOMEDICAL TECH. CO., LTD. 510(k) NO: K024007(TRADITIONAL) ATTN: TONY HUNG PHONE NO : 886 4 23755650 10F-1, 1-67, WU-CHUAN RD. SE DECISION MADE: 14-JUL-03 TAICHUNG CITY, CHINA (TAIWAN) 403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 SURGITECH, INC. 510(k) NO: K031576(TRADITIONAL) ATTN: CHRISTOPHER CROWELL PHONE NO : 760-450-0194 2424 VISTA WAY, SUITE 300 SE DECISION MADE: 31-JUL-03 OCEANSIDE, CA 92054 510(k) STATEMENT DEVICE: SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE SURGRX INC 510(k) NO: K031133(TRADITIONAL) ATTN: LINDA OLESON PHONE NO : 650-938-0424 2629-B TERMINAL BLVD. SE DECISION MADE: 03-JUL-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM SYBARITIC, INC. 510(k) NO: K024307(TRADITIONAL) ATTN: RANDALL E BERGLUND PHONE NO : 952-703-5369 9220 JAMES AVE. SOUTH SE DECISION MADE: 02-JUL-03 BLOOMINGTON, MN 55431 510(k) STATEMENT DEVICE: FILL-IN SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K031476(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 W. COLLINS AVE. SE DECISION MADE: 02-JUL-03 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM SYNTHES (USA) 510(k) NO: K031276(TRADITIONAL) ATTN: JON GILBERT PHONE NO : 484-356-9615 1690 RUSSELL RD. SE DECISION MADE: 02-JUL-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM SYNTHES (USA) 510(k) NO: K031555(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 08-JUL-03 P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYNTHES SMALL COBINATION CLAMP-MR SAFE SYNTHES (USA) 510(k) NO: K031724(TRADITIONAL) ATTN: BONNIE SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 14-JUL-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS SYNTHES (USA) 510(k) NO: K031807(SPECIAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 02-JUL-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAGA VELOCITY HUMIDIFIER TAGA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K031179(TRADITIONAL) ATTN: GARY AUSTIN PHONE NO : 440-602-8242 34675 VOKES DR STE 105 SE DECISION MADE: 17-JUL-03 EASTLAKE, OH 44095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C. DIFF CHEK - 30 TECHLAB, INC. 510(k) NO: K030991(TRADITIONAL) ATTN: DAVID M LYERLY PHONE NO : 540-953-1664 1861 PRATT DR., STE. 1030 SE DECISION MADE: 11-JUL-03 BLACKSBURG, VA 24060-6364 510(k) STATEMENT DEVICE: C. DIFF CHEK - 60 TECHLAB, INC. 510(k) NO: K030992(TRADITIONAL) ATTN: DAVID M LYERLY PHONE NO : 540-953-1664 1861 PRATT DR., STE. 1030 SE DECISION MADE: 11-JUL-03 BLACKSBURG, VA 24060-6364 510(k) STATEMENT DEVICE: MX 300 OXYGEN MONITOR TELEDYNE ANALYTICAL INSTRUMENTS 510(k) NO: K024155(TRADITIONAL) ATTN: RAY KHAJAVI PHONE NO : 626-934-1502 16830 CHESTNUT ST. SE DECISION MADE: 17-JUL-03 CITY OF INDUSTRY, CA 91749 510(k) STATEMENT DEVICE: RX300 OXYGEN ANALYZER TELEDYNE ANALYTICAL INSTRUMENTS 510(k) NO: K024228(TRADITIONAL) ATTN: RAY KHAJAVI PHONE NO : 626-934-1502 16830 CHESTNUT ST. SE DECISION MADE: 17-JUL-03 CITY OF INDUSTRY, CA 91749 510(k) STATEMENT DEVICE: TELZUIT CARDIAC MONITORING SYSTEM TELZUIT TECHNOLOGIES, INC. 510(k) NO: K031229(ABBREVIATED) ATTN: CYNTHIA J.M. NOLET PHONE NO : 919-859-4207 49 PLAIN ST. SE DECISION MADE: 09-JUL-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOSAPH TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K031891(TRADITIONAL) ATTN: KIM AVES PHONE NO : 800-262-3304 6200 JACKSON RD. SE DECISION MADE: 29-JUL-03 ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TERUMO SURGUARD 2 SAFETY NEEDLE TERUMO MEDICAL CORP. 510(k) NO: K031453(TRADITIONAL) ATTN: BARBARA SMITH PHONE NO : 410-392-7241 950 ELKTON BLVD. SE DECISION MADE: 08-JUL-03 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEH THE BINDING SITE, LTD. 510(k) NO: K031016(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 15-JUL-03 2425 WEST OLYMPIC BOULEVARD 510(k) SUMMARY AVAILABLE FROM FDA SANTA MONICA, CA 90404 DEVICE: THERIFIL BONE FILLER THERICS, INC. 510(k) NO: K031040(TRADITIONAL) ATTN: UMBERTO V PARROTTA, JR PHONE NO : 609-501-7200 115 CAMPUS DR. SE DECISION MADE: 24-JUL-03 PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI DENTAL IMPLANT ABUTMENTS THOMMEN MEDICAL, AG 510(k) NO: K031747(SPECIAL) ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 4329 GRAYDON RD. SE DECISION MADE: 02-JUL-03 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THYRO TEST THRYOTEC 510(k) NO: K030912(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT STREET SE DECISION MADE: 25-JUL-03 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINNITUS RX TINNITUS CONTROL, INC. 510(k) NO: K031624(TRADITIONAL) ATTN: RUSS PAGANO PHONE NO : 202-546-1262 719 A STREET, NE SE DECISION MADE: 24-JUL-03 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 TRANS VASCULAR INCORPORATED 510(k) NO: K031920(SPECIAL) ATTN: RICHARD E ANDERSON PHONE NO : 650-473-4500 1505-D ADAMS DR. SE DECISION MADE: 23-JUL-03 MENLO PARK, CA 94925 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K031545(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 216-351-8735 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 16-JUL-03 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: MODIFICATION TO WBR, MODEL HR U.C.G. TECHNOLOGIES LTD. 510(k) NO: K031874(SPECIAL) ATTN: DAN LAOR PHONE NO : 972 4 8546611 BUILDING # 30 MATAM SE DECISION MADE: 18-JUL-03 HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMA III TOTALSENSE TORSO COIL USA INSTRUMENTS, INC. 510(k) NO: K031365(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 18-JUL-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. 510(k) NO: K031366(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 11-JUL-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUTLER GUM PROPHY PASTE WITH NOVAMIN USBIOMATERIALS CORP. 510(k) NO: K024343(TRADITIONAL) ATTN: DAVID C GREENSPAN PHONE NO : 386-418-1551 13709 PROGRESS BLVD. SE DECISION MADE: 11-JUL-03 #23 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32615 DEVICE: VASC-ALERT VASC-ALERT L.L.C. 510(k) NO: K030456(TRADITIONAL) ATTN: JOHN KENNEDY PHONE NO : 773-334-8177 1807 W. SUNNYSIDE AVE. SE DECISION MADE: 11-JUL-03 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60640 DEVICE: VENTLAB BACTERIAL FILTER, MODEL BF100 VENTLAB CORP. 510(k) NO: K030271(TRADITIONAL) ATTN: ROBERT M KELLY PHONE NO : 336-492-2636 2934 HWY. 601 NORTH SE DECISION MADE: 07-JUL-03 MOCKSVILLE, NC 27028 510(k) STATEMENT DEVICE: SPIROSOFT VIASYS HEALTHCARE GMBH 510(k) NO: K031194(SPECIAL) ATTN: EARL DRAPER PHONE NO : 714-283-2228 22705 SAVI RANCH PKWY. SE DECISION MADE: 30-JUL-03 YORBA LINDA, CA 92887 510(k) STATEMENT DEVICE: ENDOS DC VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K030634(ABBREVIATED) ATTN: ANDREW HRYNDZA PHONE NO : 847-288-7000 11550 WEST KING ST. SE DECISION MADE: 21-JUL-03 FRANKLIN PARK, IL 60131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RSV (RADIOLOGY SYSTEM VISIODENT VISIODENT SA 510(k) NO: K031448(TRADITIONAL) ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450 110 E GRANADA BLVD. SE DECISION MADE: 31-JUL-03 STE 207 & 208; PO BOX 36 510(k) STATEMENT ORMOND BEACH, FL 32175-0036 DEVICE: SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING VISION-SCIENCES, INC. 510(k) NO: K031790(TRADITIONAL) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 02-JUL-03 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFT VIVOMETRICS, INC. 510(k) NO: K031550(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH ST. NW SE DECISION MADE: 29-JUL-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED WALSH MEDICAL DEVICES, INC. 510(k) NO: K030158(TRADITIONAL) ATTN: DAVID STILES PHONE NO : 905 844 8344 1200 SOUTH SERVICE RD. WEST SE DECISION MADE: 17-JUL-03 UNIT 3 510(k) SUMMARY AVAILABLE FROM FDA OAKVILLE, ONTARIO, CANADA L6L 5T7 DEVICE: BODY SIGNAL ECG ELECTRODE WANDY RUBBER INDUSTRIAL CO., LTD 510(k) NO: K031174(TRADITIONAL) ATTN: JANIS YANG PHONE NO : 886 2 26943185 NO.24, ALLEY 37, LANE 392 SE DECISION MADE: 10-JUL-03 FU TEH 1ST RD. 510(k) STATEMENT SHI-CHIH, CHINA (TAIWAN) 221 DEVICE: COACH 888 WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030758(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 4905 A. SAN JACINTO SE DECISION MADE: 31-JUL-03 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: COACH 888W WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030760(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 4905 A. SAN JACINTO SE DECISION MADE: 10-JUL-03 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION WIDE CORPORATION 510(k) NO: K031929(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 08-JUL-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A WIDE CORPORATION 510(k) NO: K032174(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 24-JUL-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: READI-STRAND, MODEL PSSTRAND WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K023179(TRADITIONAL) ATTN: GARY LAMOUREUX PHONE NO : 203-263-2579 426 MAIN ST. NORTH SE DECISION MADE: 02-JUL-03 WOODBURY, CT 06798-0505 510(k) STATEMENT DEVICE: CELLPLEX TCP SYNTHETIC CANCELLOUS BONE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K031817(SPECIAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 17-JUL-03 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERALITE INFINITY ENTERAL FEEDING PUMP ZEVEX INTL., INC. 510(k) NO: K031199(TRADITIONAL) ATTN: SEAN M CURRY PHONE NO : 858-675-8200 16787 BERNARDO CENTER DR. SE DECISION MADE: 09-JUL-03 SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 TOTAL 510(k)s THIS PERIOD 300 TOTAL WITH SUMMARIES 243 TOTAL WITH STATEMENTS 57
Updated August 5, 2003
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