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510(k)s Final Decisions Rendered for June 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUN-2003 THROUGH 30-JUN-2003 DEVICE: 3TP SOFTWARE OPTION 3TP LLC 510(k) NO: K031350(TRADITIONAL) ATTN: VINCENT J MCGILL PHONE NO : 212-561-3604 3 PARK AVE. SE DECISION MADE: 23-JUN-03 NEW YORK, NY 10016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLUTION FACE MASKS A PLUS INTL., INC. 510(k) NO: K031353(TRADITIONAL) ATTN: SOLOMON CHEN PHONE NO : 909-548-0890 5138 ECULYPTUS AVE. SE DECISION MADE: 19-JUN-03 CHINO, CA 91710 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS H ACCESS BIO INCORPORATE 510(k) NO: K031048(TRADITIONAL) ATTN: YOUNG HO CHOI PHONE NO : 732-246-7400 675 US HIGHWAY 1 SE DECISION MADE: 16-JUN-03 NORTH BRUNSWICK, NJ 08902 510(k) STATEMENT DEVICE: CARESTART HCG ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE 510(k) NO: K031052(TRADITIONAL) ATTN: YOUNG HO CHOI PHONE NO : 732-246-7400 675 US HIGHWAY 1 SE DECISION MADE: 13-JUN-03 NORTH BRUNSWICK, NJ 08902 510(k) STATEMENT DEVICE: SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH ACMI CORPORATION 510(k) NO: K030684(TRADITIONAL) ATTN: FRANK FUCILE PHONE NO : 508-804-2600 136 TURNPIKE RD. SE DECISION MADE: 03-JUN-03 SOUTHBOROUGH, MA 01772 510(k) STATEMENT DEVICE: BERKELEY V-10 VACUUM CURETTAGE SYSTEM ACMI CORPORATION 510(k) NO: K030935(TRADITIONAL) ATTN: FRANK FUCILE PHONE NO : 508-804-2617 136 TURNPIKE RD. SE DECISION MADE: 23-JUN-03 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENS PRO 900 ACUMED MEDICAL SUPPLIES, LTD. 510(k) NO: K023726(TRADITIONAL) ATTN: RICHARD KEEN PHONE NO : 203-329-2700 1151 HOPE ST. SE DECISION MADE: 17-JUN-03 STANFORD, CT 06907 510(k) STATEMENT DEVICE: SKYLIGHT IMAGING SYSTEM ADAC LABORATORIES 510(k) NO: K031705(TRADITIONAL) ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051 540 ALDER DR. SE DECISION MADE: 17-JUN-03 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC ADAC LABORATORIES 510(k) NO: K031872(TRADITIONAL) ATTN: CHARLENE BRUMBAUGH PHONE NO : 408-468-3619 540 ALDER DR. SE DECISION MADE: 20-JUN-03 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANTIMICROBIAL ALGINATE DRESSING ADVANCED MEDICAL SOLUTIONS LTD. 510(k) NO: K024298(TRADITIONAL) ATTN: JOHN GREEN PHONE NO : 440 160 6863500 ROAD THREE, SE DECISION MADE: 30-JUN-03 WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD DEVICE: AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) AESCULAP, INC. 510(k) NO: K031303(SPECIAL) ATTN: MATTHEW M HULL PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 04-JUN-03 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANX 10 AIR TECHNIQUES, INC. 510(k) NO: K031198(TRADITIONAL) ATTN: JOSEPH CAREY PHONE NO : 516-433-7676 70 CANTIAGUE ROCK RD. SE DECISION MADE: 20-JUN-03 HICKSVILLE, NY 11801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTERIALFLOW SYSTEM, MODEL 32A AIRCAST, INC. 510(k) NO: K024019(TRADITIONAL) ATTN: STEPHEN L KENNEY PHONE NO : 908-273-6349 92 RIVER RD. SE DECISION MADE: 03-JUN-03 SUMMIT, NJ 07901 510(k) STATEMENT DEVICE: PNEUTON VENTILATOR AIRON CORPORATION 510(k) NO: K024344(TRADITIONAL) ATTN: G. ERIC GJERDE PHONE NO : 321-723-0019 102 EAST NEW HAVEN AVE. #146 SE DECISION MADE: 03-JUN-03 MELBOURNE, FL 32901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K024360(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-513-3888 12330 STOWE DR. SE DECISION MADE: 10-JUN-03 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE-STEP PREGNANCY TEST AMERISOURCE PHARMACAL, INC. 510(k) NO: K031271(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 17-JUN-03 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANDIODYNAMICS, INC. ELVS PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K031233(TRADITIONAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 18-JUN-03 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K031626(SPECIAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 19-JUN-03 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH ANGIOMETRX INC. 510(k) NO: K024000(TRADITIONAL) ATTN: CARL YOUNGMANN PHONE NO : 206-720-1540 936 11TH AVENUE EAST SE DECISION MADE: 26-JUN-03 SEATTLE, WA 98102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZMANAGER PLUS ANIMAS CORP. 510(k) NO: K022394(TRADITIONAL) ATTN: MICHAEL J ANDREWS PHONE NO : 610-644-8990 590 E. LANCASTER AVE. SE DECISION MADE: 05-JUN-03 FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-1805M ANODIA SYSTEMS 510(k) NO: K023815(TRADITIONAL) ATTN: THAD J OVERMYER PHONE NO : 866-246-2548 514 SOUTH THIRD ST. SE DECISION MADE: 19-JUN-03 DANVILLE, KY 40422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-1890 ANODIA SYSTEMS 510(k) NO: K023896(TRADITIONAL) ATTN: THAD OVERMYER PHONE NO : 859-236-4778 514 SOUTH THIRD ST. SE DECISION MADE: 19-JUN-03 DANVILLE, KY 40422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM ARTHROCARE CORP. 510(k) NO: K031029(TRADITIONAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 19-JUN-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPH ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K031141(TRADITIONAL) ATTN: MARTINA GUNDEROTH PHONE NO : 49 451 3882864 KATHARINENSTR. 5 SE DECISION MADE: 30-JUN-03 LUEBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED ASTRA TECH, INC. 510(k) NO: K024111(TRADITIONAL) ATTN: BRUCE R MANNING PHONE NO : 508-393-3100 96 WEST MAIN ST. SE DECISION MADE: 10-JUN-03 P.O. BOX 809 510(k) SUMMARY AVAILABLE FROM FDA NORTHBOROUGH, MA 01532 DEVICE: DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K031177(TRADITIONAL) ATTN: EILEEN MCCAFFERTY PHONE NO : 441 382 422000 THE TECHNOLOGY PARK SE DECISION MADE: 19-JUN-03 DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) STATEMENT DEVICE: FLUENCY TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR 510(k) NO: K031041(ABBREVIATED) ATTN: AYMEE R BERRY PHONE NO : 480-303-2752 1625 WEST 3RD ST. SE DECISION MADE: 19-JUN-03 TEMPE, AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 BAXTER HEALTHCARE CORP. 510(k) NO: K030099(TRADITIONAL) ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335 1620 WAUKEGAN RD. SE DECISION MADE: 17-JUN-03 MCGAW PARK, IL 60085 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY BAYER HEALTHCARE, LLC 510(k) NO: K031038(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 23-JUN-03 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA CENTAUR CA 19-9 ASSAY BAYER HEALTHCARE, LLC 510(k) NO: K031393(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 24-JUN-03 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC 510(k) NO: K031644(ABBREVIATED) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 25-JUN-03 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPOPROTEIN CALIBRATOR BAYER HEALTHCARE, LLC 510(k) NO: K031682(ABBREVIATED) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 25-JUN-03 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML BD DIAGNOSTIC SYSTEMS 510(k) NO: K031429(TRADITIONAL) ATTN: KATHRYN B POWERS PHONE NO : 410-316-4260 7 LOVETON CIRCLE SE DECISION MADE: 06-JUN-03 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY BECKMAN COULTER, INC. 510(k) NO: K031506(SPECIAL) ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 02-JUN-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY BECKMAN COULTER, INC. 510(k) NO: K031606(SPECIAL) ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 20-JUN-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. 510(k) NO: K031200(SPECIAL) ATTN: CYNTHIA LACATENA PHONE NO : 201-847-6869 1 BECTON DR. SE DECISION MADE: 24-JUN-03 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VIPER INSTRUMENT BECTON, DICKINSON AND COMPANY 510(k) NO: K023955(TRADITIONAL) ATTN: COLLEN A KISTLER PHONE NO : 410-316-4988 7 LOVETON CIR. SE DECISION MADE: 24-JUN-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POS BECTON, DICKINSON AND COMPANY 510(k) NO: K031306(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 02-JUN-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURAD SCAR THERAPY BEIERSDORF, INC. 510(k) NO: K024057(TRADITIONAL) ATTN: FRANCES K WU PHONE NO : 202-737-4294 700 THIRTEENTH STREET, N.W. SE DECISION MADE: 18-JUN-03 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005-5929 DEVICE: SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K030708(TRADITIONAL) ATTN: MICHELLE SAWYER PHONE NO : 353 91 774361 BMR HOUSE SE DECISION MADE: 25-JUN-03 PARKMORE BUSINESS PARK WEST 510(k) SUMMARY AVAILABLE FROM FDA GALWAY, IRELAND DEVICE: LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URIN BIO-RAD 510(k) NO: K031231(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200 9500 JERONIMO RD. SE DECISION MADE: 18-JUN-03 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8 BIOFORM, INC. 510(k) NO: K030682(TRADITIONAL) ATTN: WILLIAM G HUBBARD PHONE NO : 262-835-9800 4133 COURTNEY ROAD, #10 SE DECISION MADE: 27-JUN-03 FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM K BIOLITEC, INC. 510(k) NO: K030700(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 04-JUN-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1 BIOMEDICAL SYSTEMS CORP. 510(k) NO: K024323(TRADITIONAL) ATTN: K. MICHAEL KROEHNKE PHONE NO : 314-576-6800 2464 WEST PORT PLAZA DR. SE DECISION MADE: 30-JUN-03 ST. LOUIS, MO 63146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAS TROPONIN I (TNI), MODEL 30 445 BIOMERIEUX, INC. 510(k) NO: K030950(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 16-JUN-03 HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-MODULAR SHOULDER SYSTEM BIOMET, INC. 510(k) NO: K030710(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 BELL DR. SE DECISION MADE: 04-JUN-03 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: HA PMI FLANGED ACETABULAR COMPONENT BIOMET, INC. 510(k) NO: K030861(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 12-JUN-03 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, IN510(k) NO: K030332(SPECIAL) ATTN: KENT HOFFMAN PHONE NO : 410-472-1888 47 R LOVETON CIRCLE SE DECISION MADE: 06-JUN-03 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210 BISCO, INC. 510(k) NO: K030951(TRADITIONAL) ATTN: STEPHEN (STEVE) SMITH PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 06-JUN-03 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE POSTERIOR CERVICAL SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K030197(TRADITIONAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711 90 BROOKSDALE DR. SE DECISION MADE: 12-JUN-03 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFIC BLACKSTONE MEDICAL, INC. 510(k) NO: K030581(SPECIAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711 90 BROOKSDALE DR. SE DECISION MADE: 26-JUN-03 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE SURGICAL TITANIUM MESH BLACKSTONE MEDICAL, INC. 510(k) NO: K030744(TRADITIONAL) ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711 90 BROOKSDALE DR. SE DECISION MADE: 27-JUN-03 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CAVERMAP SURGICAL AID BLUE TORCH MEDICAL TECHNOLOGIES 510(k) NO: K031527(SPECIAL) ATTN: FREDERICK TOBIA PHONE NO : 617-618-5105 180 WELLS AVENUE SE DECISION MADE: 05-JUN-03 NEWTON, MA 02459 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFE BOSTON SCIENTIFIC CORP. 510(k) NO: K031538(SPECIAL) ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 27-JUN-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC BOSTON SCIENTIFIC EPI 510(k) NO: K023691(TRADITIONAL) ATTN: TIMOTHY J JOHNSON PHONE NO : 408-970-7343 2525 WALSH AVE. SE DECISION MADE: 04-JUN-03 SANTA CLARA, CA 95051-1316 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTORVISION FLUORO3D BRAINLAB, AG 510(k) NO: K024192(TRADITIONAL) ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9916680 AMMERTHALSTRASSE 8 SE DECISION MADE: 11-JUN-03 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQMARK DIGITAL HOLTER BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K031466(SPECIAL) ATTN: RUOMEI ZHANG PHONE NO : 310-530-5955 3300 FUJITA ST. SE DECISION MADE: 11-JUN-03 TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO GATOR SYSTEM BYRNE MEDICAL, INC. 510(k) NO: K031773(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 24-JUN-03 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER C.R. BARD, INC. 510(k) NO: K030020(ABBREVIATED) ATTN: GLENN NORTON PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 16-JUN-03 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFT C.R. BARD, INC. 510(k) NO: K031000(TRADITIONAL) ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216 55 TECHNOLOGY DR. SE DECISION MADE: 03-JUN-03 LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI CANON U.S.A., INC. 510(k) NO: K031629(TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 06-JUN-03 LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C CANON U.S.A., INC. 510(k) NO: K031633(TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 11-JUN-03 LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TEMPORARY TITANIUM ANEURYSM CLIP CARDINAL HEALTH 510(k) NO: K031468(TRADITIONAL) ATTN: LANCE MACRCONI PHONE NO : 847-785-3312 1500 WAUKEGAN ROAD, BLDG. WM SE DECISION MADE: 20-JUN-03 MCGAW PARK, IL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARE ETS CARE REHAB AND ORTHOPAEDIC 510(k) NO: K023036(TRADITIONAL) ATTN: CHRISTIAN E HUNT PHONE NO : 703-448-9644 1124 DOMINION CT. SE DECISION MADE: 19-JUN-03 MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UFI GEL HARD C CASCADES DEVICE CONSULTING ASSOCIA510(k) NO: K030916(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 19-JUN-03 BEND, OR 97702-1923 510(k) STATEMENT DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORP. 510(k) NO: K031521(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 27-JUN-03 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORP. 510(k) NO: K031522(TRADITIONAL) ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PKWY. SE DECISION MADE: 27-JUN-03 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 CLINICAL DATA 510(k) NO: K030528(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-672-3553 1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 17-JUN-03 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-PORT CLINISURG VASCULAR PRODUCTS, LLC 510(k) NO: K030636(TRADITIONAL) ATTN: DONALD F HULTS PHONE NO : 214-691-5935 5454 AMESBURY DR., #2107 SE DECISION MADE: 05-JUN-03 DALLAS, TX 75206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 CLIO DESIGNS, INC. 510(k) NO: K023817(TRADITIONAL) ATTN: BERNARD FABRICANT PHONE NO : 617-969-7509 ONE GROVE ST. SE DECISION MADE: 25-JUN-03 WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SUR COMPUTER MOTION, INC. 510(k) NO: K030578(TRADITIONAL) ATTN: CATHY STUPAK PHONE NO : 805-685-3729 130-B CREMONA DR. SE DECISION MADE: 24-JUN-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCB COMPUTER MOTION INTERFACE CONTROLLER COMPUTER MOTION, INC. 510(k) NO: K030718(TRADITIONAL) ATTN: KEITH LOWREY PHONE NO : 805-685-3729 130-B CREMONA DR. SE DECISION MADE: 05-JUN-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K031382(SPECIAL) ATTN: KEITH LOWREY PHONE NO : 805-685-3729 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 30-JUN-03 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARIES INDICATOR CONFI-DENTAL PRODUCTS CO. 510(k) NO: K030807(TRADITIONAL) ATTN: STEPHEN RUDOLPH PHONE NO : 303-665-7535 416 SOUTH TAYLOR AVE. SE DECISION MADE: 09-JUN-03 LOUISVILLE, CO 80027-3028 510(k) STATEMENT DEVICE: ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. 510(k) NO: K031766(SPECIAL) ATTN: KAREN BRADBURN PHONE NO : 800-346-2686 750 DANIELS WAY SE DECISION MADE: 26-JUN-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402-0489 DEVICE: CORD STICK MULTIPLE DRAW SYSTEM CORD STICK CORP. 510(k) NO: K031058(TRADITIONAL) ATTN: MICHAEL MOEN PHONE NO : 209-524-4821 1400 FLORIDA AVE., SUITE 205 SE DECISION MADE: 13-JUN-03 MODESTO, CA 95350 510(k) STATEMENT DEVICE: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY CORDIS CORP. 510(k) NO: K031197(SPECIAL) ATTN: SAM MIRZA PHONE NO : 786-313-2007 14201 N.W. 60TH AVE. SE DECISION MADE: 16-JUN-03 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO CORDIS NEUROVASCULAR, INC. 510(k) NO: K030963(TRADITIONAL) ATTN: ALINA CARABALLO PHONE NO : 786-313-6518 14000 N.W. 57TH CT. SE DECISION MADE: 20-JUN-03 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CP MEDICAL BONE WAX CP MEDICAL 510(k) NO: K024372(TRADITIONAL) ATTN: SUE RIDGE PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 19-JUN-03 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESQPOD CIRCULATORY ENHANCER CPRX LLC 510(k) NO: K022906(ABBREVIATED) ATTN: JOHN F STAPLETON PHONE NO : 952-947-9590 7615 GOLDEN TRIANGLE DR. SE DECISION MADE: 11-JUN-03 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA EDEN PRAIRIE, MN 55344 DEVICE: CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER CYNOSURE, INC. 510(k) NO: K031488(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 04-JUN-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYVA EMIT II PLUS AMPHETAMINES ASSAY DADE BEHRING, INC. 510(k) NO: K031004(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-480-7558 500 GBC DR. SE DECISION MADE: 06-JUN-03 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) DADE BEHRING, INC. 510(k) NO: K031135(TRADITIONAL) ATTN: LORRAINE PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101 SE DECISION MADE: 02-JUN-03 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: "VIRGO", MODEL 9VIR1200 DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K031825(ABBREVIATED) ATTN: NIELS SORENSEN PHONE NO : 45 45 768888 DR. NEERGAARDSVEJ 5F SE DECISION MADE: 20-JUN-03 HORSHOLM, DENMARK 2970 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX DATASCOPE CORP. 510(k) NO: K031569(SPECIAL) ATTN: JOANN TAYLOR PHONE NO : 973-244-6100 15 LAW DR. SE DECISION MADE: 10-JUN-03 FAIRFIELD, NJ 07004-0011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR DATEX-OHMEDA 510(k) NO: K030990(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 25-JUN-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA HMEF 750 DATEX-OHMEDA 510(k) NO: K031653(SPECIAL) ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 20-JUN-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSOR DATEX-OHMEDA 510(k) NO: K031781(SPECIAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 25-JUN-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) DATEX-OHMEDA, INC. 510(k) NO: K031027(SPECIAL) ATTN: WILLIAM E EXNER PHONE NO : 608-221-1551 OHMEDA DR. SE DECISION MADE: 26-JUN-03 P.O. BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA MADISON, WI 53707-7550 DEVICE: AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM ( DATEX-OHMEDA, INC. 510(k) NO: K031479(SPECIAL) ATTN: AL VAN HOUDT PHONE NO : 425-657-7200 5150 220TH AVE SE SE DECISION MADE: 06-JUN-03 ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEMETECH NYLON NONABSORBABLE SUTURE DEMETECH CORP. 510(k) NO: K023028(TRADITIONAL) ATTN: LUIS ARGUELLO PHONE NO : 305-251-2700 12119 SW 131 AVE. SE DECISION MADE: 18-JUN-03 MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEMETECH POLYESTER NONABSORBABLE SUTURE DEMETECH CORP. 510(k) NO: K023030(TRADITIONAL) ATTN: LUIS ARGUELLO PHONE NO : 305-251-2700 12119 SW 131 AVE. SE DECISION MADE: 18-JUN-03 MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRP-LATEX (II)X2 SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. 510(k) NO: K030545(TRADITIONAL) ATTN: TOSHIMI MATSUNAGA PHONE NO : 025 042 7221 KAGAMIDA FACILITY SE DECISION MADE: 02-JUN-03 1-2-2 MINAMIHONCHO, 510(k) SUMMARY AVAILABLE FROM FDA GOSEN CITY, NIIGATA, JAPAN 959-1695 DEVICE: CRP (II) CALIBRATORS DENKA SEIKEN CO., LTD. 510(k) NO: K030546(TRADITIONAL) ATTN: TOSHIMI MATSUNAGA PHONE NO : 025 042 7212 KAGAMIDA FACILITY SE DECISION MADE: 02-JUN-03 1-2-2 MINAMIHONCHO, 510(k) SUMMARY AVAILABLE FROM FDA GOSEN CITY, NIIGATA, JAPAN 959-1695 DEVICE: CONTEC LIGHT DENTAURUM 510(k) NO: K030641(TRADITIONAL) ATTN: JAN W A. DOORSCHODT PHONE NO : 215-968-2858 10 PHEASANT RUN SE DECISION MADE: 10-JUN-03 NEWTOWN, PA 18940 510(k) STATEMENT DEVICE: DEPUY ACROMED VBR SYSTEM DEPUY ACROMED 510(k) NO: K031635(SPECIAL) ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 23-JUN-03 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031495(SPECIAL) ATTN: KARLA A HAM PHONE NO : 574-371-4925 700 ORTHOPAEDIC DR. SE DECISION MADE: 11-JUN-03 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: ULTRA HIGH PRESSURE INJECTOR LINES DEROYAL INDUSTRIES, INC. 510(k) NO: K023591(TRADITIONAL) ATTN: GRACIE GREENWAY PHONE NO : 865-362-1025 200 DEBUSK LN. SE DECISION MADE: 18-JUN-03 POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE DIAMETRICS MEDICAL, INC. 510(k) NO: K030035(TRADITIONAL) ATTN: NANCY RING PHONE NO : 651-638-1250 2658 PATTON RD. SE DECISION MADE: 25-JUN-03 ROSEVILLE, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALIBRATING MATERIAL, CALIBRATING STANDARDS DIAMOND DIAGNOSTICS, INC. 510(k) NO: K031159(TRADITIONAL) ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450 331 FISKE ST. SE DECISION MADE: 25-JUN-03 HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRADWEB BY DYNAMIC IMAGING, INC. DYNAMIC IMAGING INC. 510(k) NO: K031311(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 20-JUN-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 E-Z-EM, INC. 510(k) NO: K031571(SPECIAL) ATTN: STEVEN HARTMAN PHONE NO : 516-333-8230 717 MAIN ST. SE DECISION MADE: 19-JUN-03 WESTBURY, NY 11590 510(k) STATEMENT DEVICE: EBI P148 SPINAL FIXATION SYSTEM EBI, L.P. 510(k) NO: K031423(TRADITIONAL) ATTN: JON CAPARETTA PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 27-JUN-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI XFIX DFS SYSTEM EBI, L.P. 510(k) NO: K031645(SPECIAL) ATTN: ART KAUFMAN PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 25-JUN-03 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON EDWARDS LIFESCIENCES, LLC. 510(k) NO: K030944(TRADITIONAL) ATTN: JASON SMITH PHONE NO : 949-250-2662 ONE EDWARDS WAY SE DECISION MADE: 20-JUN-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES ELETROMED, INC. 510(k) NO: K030800(TRADITIONAL) ATTN: LYDIA BAYNES PHONE NO : 866-378-4672 4938 HAMDEN LN. #750 SE DECISION MADE: 11-JUN-03 BETHEDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES ELITE INTERNATIONAL, INC. 510(k) NO: K031113(TRADITIONAL) ATTN: BOBBY LING PHONE NO : 800-788-9486 18709 GREENBAY DR. SE DECISION MADE: 10-JUN-03 ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT DEVICE: ETI BIPOLAR HEMOSTATIC PROBE ENDO-THERAPEUTICS, INC. 510(k) NO: K031026(TRADITIONAL) ATTN: TODD ADKISSON PHONE NO : 727-726-2446 1183 CEDAR ST. SE DECISION MADE: 27-JUN-03 SAFETY HARBOR, FL 34695-2908 510(k) STATEMENT DEVICE: ORIA CLARIS EUROSURGICAL S.A. 510(k) NO: K023378(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LN. SUITE C-100 SE DECISION MADE: 27-JUN-03 PLEASANT HILL, CA 94529 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 EUROSURGICAL S.A. 510(k) NO: K031452(SPECIAL) ATTN: KEREN E WARDEN PHONE NO : 304-598-0525 7000 HAMPTON CENTER SE DECISION MADE: 18-JUN-03 SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA MORGANTOWN, WV 26505 DEVICE: NITREX NITINOL GUIDEWIRE EV3 CORPORATION 510(k) NO: K031864(SPECIAL) ATTN: CAROLYN ANDERSON PHONE NO : 763-398-7487 4600 NATHAN LN. SE DECISION MADE: 24-JUN-03 PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K023559(TRADITIONAL) ATTN: KEVIN SHERLOCK PHONE NO : 649 574 0100 P.O BOX 14-348 SE DECISION MADE: 12-JUN-03 PANMURE, AUCKLAND, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE USE ORAL MASK, MODEL HC455A FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K023670(TRADITIONAL) ATTN: ROBERT PETRY PHONE NO : 011 649 5740100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 12-JUN-03 EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERA FOX HOLLOW TECHNOLOGIES 510(k) NO: K024243(TRADITIONAL) ATTN: SUZON LOMMEL PHONE NO : 650-568-2521 300 SAGINAW DR. SE DECISION MADE: 20-JUN-03 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALIX PACESTAR GALIX BIOMEDICAL INSTRUMENTATION, 510(k) NO: K023080(TRADITIONAL) ATTN: JORDAN GAVRIELIDES PHONE NO : 305-534-5905 2555 COLLINS AVE., C-5 SE DECISION MADE: 11-JUN-03 MIAMI BEACH, FL 33140 510(k) STATEMENT DEVICE: ASYRA GALLOWAY TECHNOLOGIES, LLC 510(k) NO: K023355(TRADITIONAL) ATTN: JOE GALLOWAY PHONE NO : 801-766-3929 3736 PANARAMA DR. SE DECISION MADE: 24-JUN-03 SARATOGA SPRINGS, UT 84043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOBONE GE MEDICAL SYSTEMS EUROPE 510(k) NO: K031871(TRADITIONAL) ATTN: LARRY KROGER PHONE NO : 262 544 3894 283, RUE DE LA MINIERE, B.P.34 SE DECISION MADE: 20-JUN-03 BUC CEDEX, FRANCE 78533 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE VIVID 7, MODEL FC0003XX GENERAL ELECTRIC CO. 510(k) NO: K031663(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 09-JUN-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENICON LAPAROSCOPES GENICON, LC 510(k) NO: K030174(TRADITIONAL) ATTN: GARY HABERLAND PHONE NO : 321-297-1189 P.O. BOX 780038 SE DECISION MADE: 19-JUN-03 ORLANDO, FL 32878-0038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 GENTEEL TECHNOLOGY CO., LTD. 510(k) NO: K022926(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 06-JUN-03 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOBAG, MODEL HBBSD2000 GLOBAL BLOOD RESOURCES, LLC 510(k) NO: K031150(TRADITIONAL) ATTN: KEITH SAMOLYK PHONE NO : 800-942-9243 998 WINDSOR AVE. SE DECISION MADE: 23-JUN-03 WINDSOR, CT 06095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TS3 TUBING SET GLOBAL BLOOD RESOURCES, LLC 510(k) NO: K031151(TRADITIONAL) ATTN: KEITH SAMOLYK PHONE NO : 800-942-9243 998 WINDSOR AVE. SE DECISION MADE: 26-JUN-03 WINDSOR, CT 06095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUSTAIN SPACER GLOBUS MEDICAL INC. 510(k) NO: K031302(TRADITIONAL) ATTN: DANIEL S PAUL PHONE NO : 610-994-3164 303 SCHELL LN. SE DECISION MADE: 27-JUN-03 PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL EXAM GLOVES, WHITE GLORMED INTL., INC. 510(k) NO: K031104(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 10-JUN-03 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDO CUT-AWAY GUIDING CATHETER GUIDANT CORPORATION 510(k) NO: K031505(SPECIAL) ATTN: SHAH M HILALI PHONE NO : 651-582-7752 4100 HAMLINE AVE NORTH SE DECISION MADE: 25-JUN-03 ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNE IDEAS MINITAPE RP DEVICE GYNE IDEAS LTD. 510(k) NO: K023898(TRADITIONAL) ATTN: LOUIS MAZZARESE PHONE NO : 203-254-3565 150 ARAN HILL RD. SE DECISION MADE: 18-JUN-03 FAIRFIELD, CT 06824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM H & W TECHNOLOGY, LLC 510(k) NO: K014013(ABBREVIATED) ATTN: CHARLES O HANCOCK PHONE NO : 585-223-1850 P.O. BOX 20281 SE DECISION MADE: 25-JUN-03 ROCHESTER, NY 14602-0281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7C HAKKO MEDICAL CO., LTD. 510(k) NO: K030824(TRADITIONAL) ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146 4545 CREEK RD. SE DECISION MADE: 04-JUN-03 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODE HAND BIOMECHANICS LAB, INC. 510(k) NO: K030519(TRADITIONAL) ATTN: TIMOTHY R STALLINGS PHONE NO : 916-923-5073 77 SCRIPPS DR., SUITE 104 SE DECISION MADE: 10-JUN-03 SACRAMENTO, CA 95825 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS HANS RUDOLPH, INC. 510(k) NO: K030822(TRADITIONAL) ATTN: KEVIN RUDOLPH PHONE NO : 816-363-5522 7200 WYANDOTTE SE DECISION MADE: 03-JUN-03 KANSAS CITY, MO 64114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT HEALEX PRODUCTS, INC. 510(k) NO: K030727(TRADITIONAL) ATTN: MILTON HODOSH PHONE NO : 401-781-3223 243 ELMWOOD AVE. SE DECISION MADE: 05-JUN-03 PROVIDENCE, RI 02907 510(k) STATEMENT DEVICE: RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K031101(ABBREVIATED) ATTN: JOSE MONTANEZ PHONE NO : 443-367-5518 9033 RED BRANCH RD. SE DECISION MADE: 16-JUN-03 COLUMBIA, MD 21045 510(k) STATEMENT DEVICE: HEMCON BANDAGE OTC; HEMCON CATH/AID HEMCON, INC. 510(k) NO: K030946(TRADITIONAL) ATTN: JAMES F HENSEL PHONE NO : 503-245-0459 10575 SW CASCADE AVE. SE DECISION MADE: 19-JUN-03 SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA TIGARD, OR 97223 DEVICE: HOBBS MISTIFIER SPRAY CATHETER HOBBS MEDICAL, INC. 510(k) NO: K030765(TRADITIONAL) ATTN: ROB WHALEN PHONE NO : 860-684-0030 8 SPRING ST. SE DECISION MADE: 09-JUN-03 P.O. BOX 46 510(k) STATEMENT STAFFORD SPRINGS, CT 06076 DEVICE: VMATE MODEL VMM1000 HOWARD INSTRUMENTS, INC. 510(k) NO: K030948(TRADITIONAL) ATTN: JACK HOWARD PHONE NO : 205-553-4453 4749 APPLETREE LN. SE DECISION MADE: 17-JUN-03 TUSCALOOSA, AL 35405-5747 510(k) STATEMENT DEVICE: RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 ICN BIOMEDICALS, INC. 510(k) NO: K030211(TRADITIONAL) ATTN: CHARKES C.F. YU PHONE NO : 650-558-0395 1429 ROLLINS RD. SE DECISION MADE: 13-JUN-03 BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NLITE SYSTEM, MODEL#: A00-1025/A00-1033 ICN PHOTONICS LTD. 510(k) NO: K024189(TRADITIONAL) ATTN: MIKE KIERMAN PHONE NO : 441 554 755444 UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 20-JUN-03 DAFEN PARK 510(k) SUMMARY AVAILABLE FROM FDA LLANELLI, UNITED KINGDOM SA148QG DEVICE: INION OTPS BIODEGRADABLE FIXATON SYSTEM INION LTD. 510(k) NO: K030900(TRADITIONAL) ATTN: HANNA MARTTILA PHONE NO : 358 323 06600 LAAKARINKATU 2 SE DECISION MADE: 19-JUN-03 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKTROGEL, MODEL LK3001 INMED LTDA. 510(k) NO: K030887(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 13-JUN-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA PLEX ENA PROFILE 6 INOVA DIAGNOSTICS, INC. 510(k) NO: K031450(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 858-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 25-JUN-03 SAN DIEGO, CA 92131-1234 510(k) STATEMENT DEVICE: CALIBRATION PLASMA LMW HEPARIN INSTRUMENTATION LABORATORY CO. 510(k) NO: K030964(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 06-JUN-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTROL PLASMA LMW HEPARIN INSTRUMENTATION LABORATORY CO. 510(k) NO: K030965(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 06-JUN-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 INTEGRATED VASCULAR SYSTEMS, INC. 510(k) NO: K031583(SPECIAL) ATTN: SUSAN TURNER PHONE NO : 408-328-9090 743 NORTH PASTORIA AVE. SE DECISION MADE: 16-JUN-03 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TRANSPORT INCUBATOR 185 INTERNATIONAL BIOMEDICS, INC. 510(k) NO: K031096(SPECIAL) ATTN: GERALD MANNING PHONE NO : 512-973-0033 8508 CROSS PARK DR. SE DECISION MADE: 24-JUN-03 AUSTIN, TX 78754 510(k) STATEMENT DEVICE: CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,C INTERSURGICAL, INC. 510(k) NO: K024270(TRADITIONAL) ATTN: THOMAS R GUNERMAN PHONE NO : 315-451-2900 417 ELECTRONICS PKWY. SE DECISION MADE: 24-JUN-03 LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAISHOU VAGINAL SPECULUM JIANGSU KAISHOU MEDICAL APPARATUS 510(k) NO: K030761(TRADITIONAL) ATTN: GONG BO PHONE NO : 008 602 164957283 600 LIU ZHOU ROAD SE DECISION MADE: 09-JUN-03 8 BUILDING, 503 ROOM 510(k) STATEMENT SHANGHAI, CHINA 200233 DEVICE: JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 JOMED, INC. 510(k) NO: K031346(SPECIAL) ATTN: LORRY W HUFFMAN PHONE NO : 800-228-4728 2870 KILGORE RD. SE DECISION MADE: 23-JUN-03 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ KAMIYA BIOMEDICAL CO. 510(k) NO: K030687(TRADITIONAL) ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 27-JUN-03 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX KARL STORZ ENDOSCOPY 510(k) NO: K030848(TRADITIONAL) ATTN: PAUL S LEE PHONE NO : 800-421-0837 600 CORPORATE POINTE SE DECISION MADE: 02-JUN-03 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX ELECTRIC HANDPIECE SYSTEM LARES RESEARCH, INC. 510(k) NO: K031540(TRADITIONAL) ATTN: JOHN DAHLGREN PHONE NO : 530-345-1767 295 LOCKHEED AVE. SE DECISION MADE: 30-JUN-03 CHICO, CA 95973 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRABLATOR ELECTRODE LINVATEC CORP. 510(k) NO: K030720(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 03-JUN-03 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3-CCD DIGITAL CAMERA SYSTEM LINVATEC CORP. 510(k) NO: K031098(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 04-JUN-03 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS LSI SOLUTIONS 510(k) NO: K031443(ABBREVIATED) ATTN: CHRISTOPHER A KLACZYK PHONE NO : 585-869-6634 7796 VICTOR-MENDON RD. SE DECISION MADE: 18-JUN-03 VICTOR, NY 14564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMEND FRONTRUNNER GW CTO CATHETER LUMEND, INC. 510(k) NO: K031005(SPECIAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 400 CHESAPEAKE DR. SE DECISION MADE: 18-JUN-03 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBIN LUMENIS, LTD. 510(k) NO: K024093(TRADITIONAL) ATTN: ANNE WORDEN PHONE NO : 925-895-1200 2400 CONDENSA ST. SE DECISION MADE: 19-JUN-03 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAF M.K. MEDITECH CO. LTD. 510(k) NO: K031594(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 06-JUN-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 MED-TEC,INC. 510(k) NO: K021360(TRADITIONAL) ATTN: DONALD F RIIBE PHONE NO : 712-737-8688 1401 8TH ST. S.E. SE DECISION MADE: 10-JUN-03 P.O. BOX 320 510(k) STATEMENT ORANGE CITY, IA 51041 DEVICE: MEDELA PUMP IN STYLE ADVANCED BREASTPUMP MEDELA, INC. 510(k) NO: K031614(TRADITIONAL) ATTN: CHRISTOPHER L PETERSON PHONE NO : 815-363-1166 1101 CORPORATE DR. SE DECISION MADE: 06-JUN-03 MCHENRY, IL 60050-7005 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNVITRO HYADASE MEDI-CULT A/S 510(k) NO: K031228(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 24-JUN-03 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLASTFREEZE AND BLASTTHAW MEDI-CULT A/S 510(k) NO: K031486(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 27-JUN-03 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PER, MODEL MEMO MEDICAL MONITORS PTY., LTD. 510(k) NO: K030218(TRADITIONAL) ATTN: HARRY L PLATT PHONE NO : 612 934 48100 SUITE 407, OFFICE TOWERS SE DECISION MADE: 23-JUN-03 EAST GARDENS, NSW, AUSTRALIA 2036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOVIEW PRO BY MEDISON CO., LTD. MEDISON CO., LTD. 510(k) NO: K031886(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 30-JUN-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MSD CABLE REDUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K030816(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 06-JUN-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K031888(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 27-JUN-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K031655(SPECIAL) ATTN: RICHARD W TREHARNE, PHD PHONE NO : 901-344-1124 1800 PYRAMID PLACE SE DECISION MADE: 27-JUN-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO COLORADO 2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K030875(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 24-JUN-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K031533(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 13-JUN-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIM-SPINE MEDTRONIC XOMED 510(k) NO: K031510(TRADITIONAL) ATTN: MARTIN SARGENT PHONE NO : 904-434-7487 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 18-JUN-03 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRIME ECG SYSTEM MERIDIAN MEDICAL TECHNOLOGIES, INC510(k) NO: K030104(TRADITIONAL) ATTN: JAMIL LAHAM PHONE NO : 443-259-8810 10240 OLD COLUMBIA RD. SE DECISION MADE: 11-JUN-03 COLUMBIA, MD 21030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CTXA HIP EXTENDED REFERENCE DATA MINDWAYS SOFTWARE, INC. 510(k) NO: K030330(TRADITIONAL) ATTN: CHRISTOPHER CANN PHONE NO : 415-247-9930 282 SECOND ST., 4TH FL. SE DECISION MADE: 20-JUN-03 SAN FRANCISCO, CA 94105-3130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PAR MINIMED, INC. 510(k) NO: K030531(TRADITIONAL) ATTN: GERDA P RESCH PHONE NO : 818-362-5958 18000 DEVONSHIRE ST. SE DECISION MADE: 17-JUN-03 NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSULTIVA REPORT STATION, MODEL RS-1 MIRAMEDICA, INC 510(k) NO: K031248(TRADITIONAL) ATTN: WIDO MENHARDT PHONE NO : 408-858-0718 15466 LOS GATOS BLVD. SE DECISION MADE: 20-JUN-03 SUITE 109, PMB #171 510(k) SUMMARY AVAILABLE FROM FDA LOS GATOS, CA 95032 DEVICE: MINILOK QUICKANCHOR PLUS MITEK WORLDWIDE 510(k) NO: K030995(TRADITIONAL) ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188 249 VANDERBILT AVE. SE DECISION MADE: 26-JUN-03 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUFFLOK ANCHOR MITEK WORLDWIDE 510(k) NO: K031519(SPECIAL) ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188 A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 06-JUN-03 249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA NORWOOD, MA 02062 DEVICE: KLINIDRAPE SURGICAL DRAPES MOLNLYCKE HEALTH CARE 510(k) NO: K031131(TRADITIONAL) ATTN: LINDA A HENDRICKS PHONE NO : 267-685-2078 826 NEWTON YARDLEY RD. SE DECISION MADE: 10-JUN-03 NEWTON, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANMA VACUUM PUMP NANMA MFG CO., LTD. 510(k) NO: K030913(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 03-JUN-03 CROFTON, MD 21114 510(k) STATEMENT DEVICE: NANO-TICROWN NANO-WRITE CORP. 510(k) NO: K031627(TRADITIONAL) ATTN: KENNETH E KNAPP PHONE NO : 925-606-1388 2021 LAS POSITAS COURT SE DECISION MADE: 11-JUN-03 SUITE 121 510(k) SUMMARY AVAILABLE FROM FDA LIVERMORE, CA 94551 THIRD PARTY REVIEW DEVICE: DETECTAR, MODEL N123-MI NEKS TECHNOLOGIES 510(k) NO: K023367(TRADITIONAL) ATTN: CHARLES H KYPER PHONE NO : 919-960-0049 103 NOLEN LN. SE DECISION MADE: 25-JUN-03 CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 NEW STAR LASERS, INC. 510(k) NO: K024259(TRADITIONAL) ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912 9085 FOOTHILLS BLVD. SE DECISION MADE: 20-JUN-03 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART BAG MO O-TWO SYSTEMS INTERNATIONAL INC. 510(k) NO: K021328(TRADITIONAL) ATTN: KEVIN BOWDEN PHONE NO : 905 677 9410 7575 KIMBEL ST. SE DECISION MADE: 26-JUN-03 MISSISSAUGA,ONTARIO, CANADA L5S 1C510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE M2-PE MICROKERATOME BLADES OASIS MEDICAL, INC. 510(k) NO: K030401(TRADITIONAL) ATTN: YVONNE FERNANDEZ PHONE NO : 909-305-5400 512 S. VERMONT AVE. SE DECISION MADE: 19-JUN-03 GLENDORA, CA 91740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HF MODULE WITH TRANSDUCERS OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K031391(SPECIAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 RT 17 S SE DECISION MADE: 20-JUN-03 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 OPUS MEDICAL, INC. 510(k) NO: K031083(TRADITIONAL) ATTN: JAMES W HART PHONE NO : 949-234-0400 27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 12-JUN-03 SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT DEVICE: PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV OSCOR INC. 510(k) NO: K031164(SPECIAL) ATTN: MILA DOCKOCIL PHONE NO : 727-937-2511 3816 DE SOTO BLVD. SE DECISION MADE: 19-JUN-03 PALM HARBOR, FL 34683 510(k) STATEMENT DEVICE: OSMONICS SOLUTION DELIVERY SYSTEM, OZONE GENERATOR OSMONICS MEDICAL SYSTEMS 510(k) NO: K023011(TRADITIONAL) ATTN: KRISTINE KALISZEWSKI PHONE NO : 253-395-2200 7848 S. 202ND ST. SE DECISION MADE: 26-JUN-03 KENT, WA 98032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTI BONE CEMENT PLUG OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K030608(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 12-JUN-03 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: PALOMAR LIGHTCUBE PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K024179(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LN. SE DECISION MADE: 04-JUN-03 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBV VCA-P18 IGG ELISA PANBIO LIMITED 510(k) NO: K030863(TRADITIONAL) ATTN: HELEN JENNINGS PHONE NO : 61 7 33571177 116 LUTWYCHE RD. SE DECISION MADE: 27-JUN-03 WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS (ERTAPENEM) PASCO LABORATORIES, INC. 510(k) NO: K031103(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 12-JUN-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K031205(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 13-JUN-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTACT LENS STORAGE CASE PELICAN PRODUCTS 510(k) NO: K030987(TRADITIONAL) ATTN: CAROL NOBEL PHONE NO : 970-245-4091 611 EISENHAUER ST. SE DECISION MADE: 12-JUN-03 GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 PEREGRINE SURGICAL LTD. 510(k) NO: K031023(TRADITIONAL) ATTN: TODD RICHMOND PHONE NO : 215-348-0456 51 BRITAIN DR. SE DECISION MADE: 27-JUN-03 NEW BRITAIN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031021(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 410-837-1751 1301 DEFENCE HIGHWAY SE DECISION MADE: 13-JUN-03 GAMBRILLS, MD 21034 510(k) STATEMENT DEVICE: POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031414(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 410-793-0484 1301 DEFENCE HIGHWAY SE DECISION MADE: 26-JUN-03 GAMBRILLS, MD 21034 510(k) STATEMENT DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORE PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031591(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 410-837-1751 1301 DEFENCE HIGHWAY SE DECISION MADE: 26-JUN-03 GAMBRILLS, MD 21034 510(k) STATEMENT DEVICE: PHILIPS EASYDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K031535(SPECIAL) ATTN: LYNN T HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 17-JUN-03 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021-3003 DEVICE: SENSE BODY COIL PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K031095(TRADITIONAL) ATTN: DUANE C PRASCHAN PHONE NO : 440-483-5743 595 MINER RD. SE DECISION MADE: 20-JUN-03 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNILUX BLUE PHOTO THERAPEUTICS LIMITED 510(k) NO: K030883(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LN. SE DECISION MADE: 18-JUN-03 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMO PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K023333(ABBREVIATED) ATTN: KOI-YONG LIM PHONE NO : 603 326 40784 LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 23-JUN-03 SUNGAI SEMBILANG 510(k) STATEMENT JERAM, SELANGOR, MALAYSIA 45800 DEVICE: PLUS ORTHOPEDICS CEMENTED HIP STEM PLUS ORTHOPEDICS 510(k) NO: K031165(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 06-JUN-03 ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS PORTEX LTD. 510(k) NO: K031622(TRADITIONAL) ATTN: STEVE OGILVIE PHONE NO : 004 413 03260551 MILITARY ROAD SE DECISION MADE: 26-JUN-03 HYTHE, KENT 510(k) SUMMARY AVAILABLE FROM FDA ENGLAND CT21 6DB, UNITED KINGDOM DEVICE: SPECTRAPULSE PRIMARY TECHNOLOGY, LLC. 510(k) NO: K031680(TRADITIONAL) ATTN: STEPHEN ALMEIDA PHONE NO : 813-288-0261 813 S. WESTSHORE BLVD. SE DECISION MADE: 24-JUN-03 TAMPA, FL 33609 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K030444(TRADITIONAL) ATTN: JOSEPH J.E. PEREIRA PHONE NO : 914 842 413063 PLOT NO:14-A COCHIN SPECIAL SE DECISION MADE: 05-JUN-03 ECONOMIC ZONE 510(k) STATEMENT KAKKANAD, KOCHI, KERALA, INDIA 682 030 DEVICE: POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTE PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K030445(TRADITIONAL) ATTN: JOSEPH J.E. PEREIRA PHONE NO : 91 484 2413063 14-A, COCHIN SPECIAL ECONOMIC SE DECISION MADE: 05-JUN-03 ZONE 510(k) STATEMENT KAKKANAD, COCHIN, KERALA, INDIA 682037 DEVICE: PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM PRIZM MEDICAL, INC. 510(k) NO: K024181(TRADITIONAL) ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DR. SE DECISION MADE: 26-JUN-03 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URINARY CATHETERS PROMEDIC, INC. 510(k) NO: K031409(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 WEST WATERVIEW CT. SE DECISION MADE: 17-JUN-03 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE PT. MANDIRI INTI BUANA 510(k) NO: K031754(TRADITIONAL) ATTN: NG POY SIN PHONE NO : 62 61 4566506 JL. LISTRIK NO. 6 SE DECISION MADE: 30-JUN-03 MEDAN, INDONESIA 20112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) QC SCIENCES, LLC 510(k) NO: K023335(TRADITIONAL) ATTN: JUNQI QIAN PHONE NO : 804-288-6564 2807 N. PARHAM SE DECISION MADE: 18-JUN-03 SUITE 114 510(k) SUMMARY AVAILABLE FROM FDA RICHMOND, VA 23294 DEVICE: EKGCARD SYSTEM QRS DIAGNOSTIC, LLC. 510(k) NO: K030535(TRADITIONAL) ATTN: BRAD SORENSON PHONE NO : 763-559-8492 14755 27TH AVE.NORTH SE DECISION MADE: 11-JUN-03 PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRESSURE WIRE SENSOR, MODELS 12004/12304 RADI MEDICAL SYSTEMS AB 510(k) NO: K031662(SPECIAL) ATTN: MATS GRANLUND PHONE NO : 46 18 161000 PALMBLADSGATAN 10 SE DECISION MADE: 06-JUN-03 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINSTATION RADIANCY (ISRAEL) LTD. 510(k) NO: K030897(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 19-JUN-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO REMSTAR AUTO CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K031460(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 24-JUN-03 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE TEMPORARY PACING WIRE RIVER MEDICAL, INC. 510(k) NO: K023174(TRADITIONAL) ATTN: MARY ANN GREENAWALT PHONE NO : 503-230-1280 836 NE 24TH AVE. SE DECISION MADE: 11-JUN-03 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K031756(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 25-JUN-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUSCH GUIDED CHOLANGIOGRAPHY CATHETER RUSCH INTL. 510(k) NO: K023666(TRADITIONAL) ATTN: RICK LYKINS PHONE NO : 603-532-0204 50 PLANTATION DR. SE DECISION MADE: 17-JUN-03 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYS RUSCH INTL. 510(k) NO: K030559(TRADITIONAL) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-0204 50 PLANTATION DR. SE DECISION MADE: 30-JUN-03 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFERENTIAL STIMULATOR, MODEL NETWAVE RYAN TELEMEDICINE 510(k) NO: K031884(TRADITIONAL) ATTN: JIM KLETT PHONE NO : 800-495-7926 1011 BRIOSO DR., SUITE 102 SE DECISION MADE: 30-JUN-03 COSTA MESA, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY SALIMETRICS LLC. 510(k) NO: K031348(SPECIAL) ATTN: EVE SCHWARTZ PHONE NO : 814-234-7748 101 INNOVATION BLVD. SE DECISION MADE: 10-JUN-03 SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA STATE COLLEGE, PA 16803-6605 DEVICE: COOL CURE SAMM, INC. 510(k) NO: K030811(TRADITIONAL) ATTN: W. EDWARD JOHANSEN PHONE NO : 310-826-4902 11661 SAN VICENTE BLVD. SE DECISION MADE: 10-JUN-03 LOS ANGELES, CA 90049 510(k) STATEMENT DEVICE: MIRACLE 98 SB LUCIUS, INC. 510(k) NO: K031010(TRADITIONAL) ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814 9778 KATELLA AVE. STE. 205 SE DECISION MADE: 25-JUN-03 ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGLIFE C/MAGLIFE C PLUS SCHILLER MEDICAL S.A. 510(k) NO: K023195(ABBREVIATED) ATTN: COURT GOEHRY PHONE NO : 333 886 33600 4 RUE LOUIS PASTEUR SE DECISION MADE: 03-JUN-03 ZAE SUD BP 90050 510(k) SUMMARY AVAILABLE FROM FDA WISSEMBOURG CEDEX, FRANCE 67162 DEVICE: PROFILE 1064 LASER SYSTEM SCITON, INC. 510(k) NO: K023881(TRADITIONAL) ATTN: JAY M PATEL PHONE NO : 650-493-9155 845 COMMERCIAL ST. SE DECISION MADE: 13-JUN-03 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMIN SGMP CO., LTD. 510(k) NO: K030993(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUN-03 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GL SGMP CO., LTD. 510(k) NO: K030994(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUN-03 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHANCHUAN SYRINGE SHANGDONG ZIBO SHANCHUAN MEDICAL I510(k) NO: K021993(TRADITIONAL) ATTN: HAIRONG CHE PHONE NO : 281-635-7686 12951 BRIAR FOREST DRIVE # 303 SE DECISION MADE: 03-JUN-03 HOUSTON, TX 77077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHELHIGH BIORING SHELHIGH, INC. 510(k) NO: K023940(TRADITIONAL) ATTN: SHLOMO GABBAY PHONE NO : 908-206-7806 650 LIBERTY AVE. SE DECISION MADE: 04-JUN-03 UNION, NJ 07083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS MICRO2+ WITH VAI SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030640(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 03-JUN-03 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030738(TRADITIONAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 06-JUN-03 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X SINTEA BIOTECH, INC. 510(k) NO: K031154(TRADITIONAL) ATTN: MARIANNE GRUNWALDT PHONE NO : 305-673-6226 407 LINCOLN RD. SUITE 10L SE DECISION MADE: 24-JUN-03 MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMISSON STABILIZATION SYSTEM SMISSON-CARTLEDGE 510(k) NO: K021979(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 27-JUN-03 IRVINE, CA 92606 510(k) STATEMENT DEVICE: INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY SMITH & NEPHEW, INC. 510(k) NO: K031605(SPECIAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN RD. SE DECISION MADE: 18-JUN-03 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR SMITH & NEPHEW, INC. 510(k) NO: K031675(SPECIAL) ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365 150 MINUTEMAN RD. SE DECISION MADE: 20-JUN-03 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTAC SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K030842(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LN. SE DECISION MADE: 06-JUN-03 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: MERDOC SYSTEM STRYKER ENDOSCOPY 510(k) NO: K022393(TRADITIONAL) ATTN: KIRAN JAVADEKAR PHONE NO : 408-754-2241 5900 OPTICAL CT. SE DECISION MADE: 05-JUN-03 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER NAVIGATION SYSTEM-KNEE MODULE STRYKER LEIBINGER 510(k) NO: K022579(TRADITIONAL) ATTN: KELLI J BITTERBURG PHONE NO : 877-534-2464 4100 EAST MILHAM AVE. SE DECISION MADE: 02-JUN-03 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK SURGISTAR, INC. 510(k) NO: K030891(TRADITIONAL) ATTN: JONATHAN WOODWARD PHONE NO : 760-431-7400 6068 CORTE DEL CEDRO SE DECISION MADE: 17-JUN-03 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE S SWISS ORTHOPEDIC SOLUTIONS INC 510(k) NO: K031609(TRADITIONAL) ATTN: BOB BENNETT PHONE NO : 610-524-8142 26 TURNSTONE WAY SE DECISION MADE: 09-JUN-03 DOWNINGTON, PA 19335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE SYNTHES (USA) 510(k) NO: K031573(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 06-JUN-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM SYNTHES (USA) 510(k) NO: K031725(TRADITIONAL) ATTN: BONNIE SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 24-JUN-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 SYRINGEX MEDICAL, INC. 510(k) NO: K031065(TRADITIONAL) ATTN: JOHN JONES PHONE NO : 801-553-2150 2311 BEAR HILLS COURT SE DECISION MADE: 23-JUN-03 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOMEND TEI BIOSCIENCES INC. 510(k) NO: K031188(ABBREVIATED) ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 27-JUN-03 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER THE KENDALL COMPANY DIV. OF TYCO H510(k) NO: K024010(TRADITIONAL) ATTN: DAVID A OLSON PHONE NO : 508-261-8530 15 HAMPSHIRE ST. SE DECISION MADE: 11-JUN-03 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US TYCO HEALTHCARE NANCY 510(k) NO: K031470(SPECIAL) ATTN: JAMES BONDS PHONE NO : 925-463-4371 NELLCOR PURITAN BENNETT DIV. SE DECISION MADE: 05-JUN-03 4280 HACIENDA DRIVE 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: U&I;, OPTIMA, SPINAL SYSTEM U&I; CORP., AMERICA 510(k) NO: K031585(SPECIAL) ATTN: PATRICK MOORE PHONE NO : 801-262-3100 6132 SOUTH 380 WEST, SE DECISION MADE: 27-JUN-03 MURRAY, UT 84107-6988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U & I AMERICA SPINAL HOOK SYSTEM U&I; CORP., AMERICA 510(k) NO: K031595(TRADITIONAL) ATTN: PATRICK MOORE PHONE NO : 801-262-3100 6132 SOUTH 380 WEST, SUITE 200 SE DECISION MADE: 24-JUN-03 MURRAY, UT 84107-6988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UF BRACHYTHERAPY STAND UNIVERSITY OF FLORIDA 510(k) NO: K023430(TRADITIONAL) ATTN: PATSY J TRISLER PHONE NO : 301-652-5344 5610 WISCONSIN AVENUE #304 SE DECISION MADE: 24-JUN-03 CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECLIPSE VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K030981(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 24-JUN-03 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. 510(k) NO: K030654(TRADITIONAL) ATTN: DEBORAH JENSEN PHONE NO : 763-656-4349 2495 XENIUM LN. NORTH SE DECISION MADE: 18-JUN-03 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYOGLUE VITROLIFE SWEDEN AB 510(k) NO: K031015(TRADITIONAL) ATTN: NINA ARVIDSSON PHONE NO : 463 172 180000 MOLNDALSVAGEN 30 SE DECISION MADE: 23-JUN-03 GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVATHERM THEMPERATURE MEASUREMENT SYSTEM VIVANT MEDICAL, INC. 510(k) NO: K031556(TRADITIONAL) ATTN: STEVEN KIM PHONE NO : 650-694-2900 1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 23-JUN-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINAL VARNISH LC VOCO GMBH 510(k) NO: K030844(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 13-JUN-03 BEND, OR 97702 510(k) STATEMENT DEVICE: WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET WAKO CHEMICALS, USA, INC. 510(k) NO: K024280(TRADITIONAL) ATTN: TONYA MALLORY PHONE NO : 804-271-7677 1600 BELLWOOD RD. SE DECISION MADE: 06-JUN-03 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZE EXTERNAL MANDIBULAR DISTRACTOR WALTER LORENZ SURGICAL, INC. 510(k) NO: K031696(SPECIAL) ATTN: KIM REED PHONE NO : 904-741-9443 1520 TRADEPORT DR. SE DECISION MADE: 17-JUN-03 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDFIRE SELF DRILLING SCREWS WALTER LORENZ SURGICAL, INC. 510(k) NO: K031751(SPECIAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 26-JUN-03 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WARTNER PRO WARTNER MEDICAL PRODUCTS 510(k) NO: K030838(TRADITIONAL) ATTN: NANCY LUM-WILSON PHONE NO : 905 884 7855 65 AVA CRESCENT SE DECISION MADE: 27-JUN-03 RICHMOND HILL, ONTARIO, CANADA L4B510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTA PRESSOVER WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K031264(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 497 231 3705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 12-JUN-03 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGINE REFLEX WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K031326(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 49 723 13705219 SCHWENNINGER STRASSE 13 SE DECISION MADE: 17-JUN-03 PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP WINNER INDUSTRIES (SHENZHEN) CO., 510(k) NO: K023755(TRADITIONAL) ATTN: MING XIE PHONE NO : 949-261-5339 17815 SKY PARK CIRCLE SE DECISION MADE: 10-JUN-03 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92614 DEVICE: HI-FLO THERME PNEU 45, WISAP #7083, 7083V WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K031014(TRADITIONAL) ATTN: HORST SEMM PHONE NO : 490 810 489080 RUDOLF-DIESEL-RING 20 SE DECISION MADE: 27-JUN-03 SAUERLACH, GERMANY D-82054 510(k) STATEMENT DEVICE: READI-STRAND, MODEL PSSTRAND WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K022705(TRADITIONAL) ATTN: GARY LAMOUREUX PHONE NO : 203-263-2579 426 MAIN ST. NORTH SE DECISION MADE: 09-JUN-03 P.O. BOX 505 510(k) STATEMENT WOODBURY, CT 06798-0505 DEVICE: YA MEI FIRST AID KIT YA MEI TECHNOLOGY CO., LTD. 510(k) NO: K031130(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LN. SE DECISION MADE: 27-JUN-03 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K031384(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 17-JUN-03 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM ZIMMER, INC. 510(k) NO: K030724(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 574-372-4219 P.O. BOX 708 SE DECISION MADE: 03-JUN-03 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 ZIMMER, INC. 510(k) NO: K031572(SPECIAL) ATTN: KAREN CAIN PHONE NO : 574-372-4219 P.O. BOX 708 SE DECISION MADE: 24-JUN-03 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID IMF ZYGOMATICS LTD. 510(k) NO: K030605(TRADITIONAL) ATTN: CAROL MACDONALD PHONE NO : 440 780 1655887 20A MONTPELIER VALE SE DECISION MADE: 27-JUN-03 LONDON SE3 0TA, UNITED KINGDOM 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 265 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 45
Updated 7/8/2003
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