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510(k)s Final Decisions Rendered for December 2002 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-DEC-2002 THROUGH 31-DEC-2002 DEVICE: AAP CANNULATED SCREWS AAP IMPLANTATE AG 510(k) NO: K021233(TRADITIONAL) ATTN: CHRISTIAN ABEL PHONE NO : 493 075 019190 LORENZWEG 5 SE DECISION MADE: 09-DEC-02 BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 ABBOT LABORATORIES 510(k) NO: K024084(SPECIAL) ATTN: FRANK POKROP PHONE NO : 847-937-8473 200 ABBOTT PARK ROAD SE DECISION MADE: 31-DEC-02 ABBOTT PARK, IL 60064-6187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES 510(k) NO: K023397(TRADITIONAL) ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106 200 ABBOTT PARK ROAD SE DECISION MADE: 16-DEC-02 DEPT 9V6, BLDG. AP34-2 510(k) SUMMARY AVAILABLE FROM FDA ABBOTT PARK, IL 60064-3537 DEVICE: MODIFICATION TO ALKP ABBOTT LABORATORIES 510(k) NO: K023807(SPECIAL) ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1920 HURD DRIVE SE DECISION MADE: 26-DEC-02 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACELL UBM LYOPHILIZED WOUND DRESSING ACELL, INC 510(k) NO: K021637(TRADITIONAL) ATTN: PATSY J TRISER PHONE NO : 202-835-1346 815 CONNECTICUT AVE NW SE DECISION MADE: 19-DEC-02 SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: ACELL UBM HYDRATED WOUND DRESSING ACELL, INC 510(k) NO: K022854(TRADITIONAL) ATTN: PATSY J TRISLER PHONE NO : 202-835-1346 815 CONNECTICUT AVE NW SE DECISION MADE: 30-DEC-02 SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES ACUTRONIC MEDICAL SYSTEMS AG 510(k) NO: K012691(TRADITIONAL) ATTN: TERRY TORZALA PHONE NO : 520-743-7874 PO BOX 85820 SE DECISION MADE: 20-DEC-02 TUCSON, AZ 85754-5820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K023226(TRADITIONAL) ATTN: PAUL J NOWACKI PHONE NO : 714-247-8601 1700 E. ST. ANDREW PLACE SE DECISION MADE: 10-DEC-02 P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA, CA 92799-5162 DEVICE: STEELEX STERNUM SET AESCULAP, INC. 510(k) NO: K023411(TRADITIONAL) ATTN: GEORG KELLER PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 19-DEC-02 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLUMBUS (CR) TOTAL KNEE SYSTEM AESCULAP, INC. 510(k) NO: K023788(SPECIAL) ATTN: JOYCE KILROY PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 13-DEC-02 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-11 AG GARMENTS 510(k) NO: K023212(TRADITIONAL) ATTN: ATHENA SHUDDE PHONE NO : 619-234-2266 1762 COLUMBIA STREET SE DECISION MADE: 13-DEC-02 SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K023264(TRADITIONAL) ATTN: RENEE L FLUET PHONE NO : 858-458-7563 10221 WATERIDGE CIR. SE DECISION MADE: 19-DEC-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW TCA URINE TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K022693(ABBREVIATED) ATTN: NAISHU WANG PHONE NO : 858-513-5888 12330 STOWE DRIVE SE DECISION MADE: 09-DEC-02 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. 510(k) NO: K023936(SPECIAL) ATTN: ELI M ORBACH PHONE NO : 972 299 32768 P.O. BOX 6718 SE DECISION MADE: 20-DEC-02 EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELIN ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K024102(SPECIAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN RD. SE DECISION MADE: 18-DEC-02 BLDG K 510(k) SUMMARY AVAILABLE FROM FDA MCGRAW PARK, IL 60085 DEVICE: ALOKA SSD-3500 ULTRASOUND SYSTEM ALOKA CO., LTD. 510(k) NO: K023996(TRADITIONAL) ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 18-DEC-02 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM ALPHATEC MFG., INC. 510(k) NO: K023299(TRADITIONAL) ATTN: ELLEN A HICKS PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 11-DEC-02 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDICA DRUG SCREEN METHAPHETAMINE TEST AMEDICA BIOTECH, INC. 510(k) NO: K023101(TRADITIONAL) ATTN: JEFF CHEN PHONE NO : 510-785-5980 28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 16-DEC-02 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDICA DRUG SCREEN AMPHETAMINE TEST AMEDICA BIOTECH, INC. 510(k) NO: K023104(TRADITIONAL) ATTN: JEFF CHEN PHONE NO : 510-785-5980 28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 16-DEC-02 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDICA DRUG SCREEN PHENCYCLIDINE TEST AMEDICA BIOTECH, INC. 510(k) NO: K023109(TRADITIONAL) ATTN: JEFF CHEN PHONE NO : 510-785-5980 28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 16-DEC-02 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL AMERICAN MAMMOGRAPHICS, INC. 510(k) NO: K023229(TRADITIONAL) ATTN: ADRIAN PALMER PHONE NO : 423-624-9530 1302 SHAWHAN TERRACE SE DECISION MADE: 13-DEC-02 CHATTANOOGA, TN 37411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSINO TRACHEOSTOMY CARE TRAY AMSINO INTERNATIONAL, INC. 510(k) NO: K023276(TRADITIONAL) ATTN: DEAN R GAUF PHONE NO : 909-390-5688 4501 BRICKELL PRIVADO STREET SE DECISION MADE: 09-DEC-02 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: SMARTSTEP SYSTEM ANDANTE MEDICAL DEVICE, LTD. 510(k) NO: K023161(TRADITIONAL) ATTN: ORLY MAOR PHONE NO : 972 9 7718130 117 AHUZAH STREET SE DECISION MADE: 10-DEC-02 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANDREWS INTRODUCER, MODEL ASI01 ANDREWS SURGICAL INNOVATIONS, LTD.510(k) NO: K023173(TRADITIONAL) ATTN: EMMET ANDREWS PHONE NO : 353 872 39223 16 GROVE LAWN SE DECISION MADE: 18-DEC-02 MALAHIDE, DUBLIN, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTACHECK MENOPAUSE PREDICTOR TEST APPLIED BIOTECH, INC. 510(k) NO: K023408(TRADITIONAL) ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483 10237 FLANDERS COURT SE DECISION MADE: 20-DEC-02 P.O. BOX 9433 510(k) SUMMARY AVAILABLE FROM FDA RANCHO SANTA FE,, CA 92067 DEVICE: PREPARE ADMINISTRATION SET APPRO HEALTHCARE, INC. 510(k) NO: K023769(TRADITIONAL) ATTN: JOHN R SEMLER PHONE NO : 716-855-1068 847 MAIN STREET SE DECISION MADE: 30-DEC-02 BUFFALO, NY 14203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROJAN MINT TINGLE BRAND LATEX CONDOMS ARMKEL, LLC. 510(k) NO: K023405(ABBREVIATED) ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748 469 NORTH HARRISON ST SE DECISION MADE: 16-DEC-02 PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC. 510(k) NO: K023119(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 18-DEC-02 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX OPES ELECTRODES AND ACCESSORIES ARTHREX, INC. 510(k) NO: K023986(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 17-DEC-02 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 12 ARTHRONET MEDICAL, INC. 510(k) NO: K023777(SPECIAL) ATTN: CAROLINA SCHABER PHONE NO : 760-436-3766 8 HAMMOND, SUITE 108 SE DECISION MADE: 11-DEC-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 ATI MEDICAL, INC. 510(k) NO: K020683(TRADITIONAL) ATTN: MICHAEL WIENHOLT PHONE NO : 858-487-7243 10954-A VIA FRONTERA SE DECISION MADE: 17-DEC-02 SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULI ATLANTIC PRODUCTS, INC. 510(k) NO: K023108(TRADITIONAL) ATTN: MAHBUBUR RAHMAN PHONE NO : 516-827-0816 24 CENTER STREET SE DECISION MADE: 03-DEC-02 HICKSVILLE, NY 11801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOLENS CLEANING AND DISINFECTING UNIT AUTOLENS INC. 510(k) NO: K021699(TRADITIONAL) ATTN: RICHARD E LIPPMAN PHONE NO : 301-330-4660 17003 HORN POINT DRIVE SE DECISION MADE: 16-DEC-02 GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRIST IMPLANT AVANTA ORTHOPAEDICS, INC. 510(k) NO: K021859(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 858-922-3974 9369 CARROLL PARK DRIVE SE DECISION MADE: 02-DEC-02 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: DRX5000 AXIOM USA. INC 510(k) NO: K023160(TRADITIONAL) ATTN: JIM GIBSON PHONE NO : 813-969-2414 3830 GUNN HWY SE DECISION MADE: 20-DEC-02 TAMPA, FL 33624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 05 BACCHUS VASCULAR, INC. 510(k) NO: K022640(SPECIAL) ATTN: GREGORY J MATHISON PHONE NO : 408-980-8300 3110 CORONADO DR. SE DECISION MADE: 02-DEC-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INF BACCHUS VASCULAR, INC. 510(k) NO: K023514(TRADITIONAL) ATTN: GREGORY J MATHISON PHONE NO : 408-980-8300 3110 CORONADO DR. SE DECISION MADE: 02-DEC-02 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV 510(k) NO: K022773(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 13-DEC-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV 510(k) NO: K023322(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 23-DEC-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGETILE BARCO NV 510(k) NO: K023339(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 23-DEC-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV 510(k) NO: K023340(TRADITIONAL) ATTN: FRANK FERGUSOPN PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 23-DEC-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV 510(k) NO: K023341(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 23-DEC-02 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY BAXTER HEALTHCARE CORP. 510(k) NO: K013562(TRADITIONAL) ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335 1620 WAUKEGAN ROAD SE DECISION MADE: 12-DEC-02 MC GAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER A BAYER CORP. 510(k) NO: K022288(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE. SE DECISION MADE: 17-DEC-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED M BAYER DIAGNOSTICS CORP. 510(k) NO: K022177(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 17-DEC-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMMONIA ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. 510(k) NO: K023841(TRADITIONAL) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE SE DECISION MADE: 24-DEC-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 BAYLIS MEDICAL CO., INC. 510(k) NO: K023334(TRADITIONAL) ATTN: AMANDA HARTLEY PHONE NO : 905 602 4875 5160 EXPLORER DR. #33 SE DECISION MADE: 31-DEC-02 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT DEVICE: ACCESS TOTAL T4 ASSAY BECKMAN COULTER, INC. 510(k) NO: K023369(TRADITIONAL) ATTN: DENISE THOMPSON PHONE NO : 952-368-1202 1000 LAKE HAZELTINE DR. SE DECISION MADE: 09-DEC-02 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS TOTAL BHCG BECKMAN COULTER, INC. 510(k) NO: K023480(TRADITIONAL) ATTN: DENISE THOMPSON PHONE NO : 952-368-1202 1000 LAKE HAZELTINE DR. SE DECISION MADE: 20-DEC-02 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY BECKMAN COULTER, INC. 510(k) NO: K023597(TRADITIONAL) ATTN: MARA CALER PHONE NO : 858-621-4583 7330 CARROLL RD. SE DECISION MADE: 11-DEC-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD DIRECTIGEN EZ RSV KIT BECTON DICKINSON & CO. 510(k) NO: K022133(TRADITIONAL) ATTN: COLLEEN A KISTLER PHONE NO : 410-316-4988 7 LOVETON CIR. SE DECISION MADE: 10-DEC-02 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECTON DICKINSON DIABETES SOFTWARE BECTON DICKINSON & CO. 510(k) NO: K023219(TRADITIONAL) ATTN: JOHN SCHALAGO PHONE NO : 201-847-5663 1 BECTON DRIVE SE DECISION MADE: 06-DEC-02 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. 510(k) NO: K024109(SPECIAL) ATTN: JOHN A SCHALGO PHONE NO : 201-847-5663 1 BECTON DRIVE SE DECISION MADE: 30-DEC-02 FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 BECTON, DICKINSON AND COMPANY 510(k) NO: K023527(TRADITIONAL) ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 23-DEC-02 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16U BECTON, DICKINSON AND COMPANY 510(k) NO: K023634(TRADITIONAL) ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 24-DEC-02 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON AND COMPANY 510(k) NO: K023858(TRADITIONAL) ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260 7 LOVETON CIR. SE DECISION MADE: 20-DEC-02 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6.0 X 5.7MM DENTAL IMPLANT BICON, INC. 510(k) NO: K010185(TRADITIONAL) ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363 123 MORTON ST., 2ND FL. SE DECISION MADE: 30-DEC-02 BOSTON, MA 02130 510(k) STATEMENT DEVICE: BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 BIOCHECK, INC. 510(k) NO: K022660(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 19-DEC-02 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: COLLATEK HYDROGEL BIOCORE MEDICAL TECHNOLOGIES, INC.510(k) NO: K022995(TRADITIONAL) ATTN: AJAY KUMAR PHONE NO : 301-625-6818 11800 TECH ROAD, SE DECISION MADE: 02-DEC-02 SUITE # 240 510(k) SUMMARY AVAILABLE FROM FDA SILVER SPRING, MD 20904-1908 DEVICE: GELSPHERES EMBOLIC AGENT BIOCURE, INC. 510(k) NO: K023089(TRADITIONAL) ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH STREET SE DECISION MADE: 16-DEC-02 FT. LAUDERDALE, FL 33332-1111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVE HUMERAL FRACTURE SYSTEM BIOMET ORTHOPEDICS, INC. 510(k) NO: K023063(TRADITIONAL) ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 13-DEC-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESS-FIT HEAD RESURFACING DEVICE BIOMET ORTHOPEDICS, INC. 510(k) NO: K023188(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 11-DEC-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR HEAD BONE SCREW BIOMET, INC. 510(k) NO: K022952(TRADITIONAL) ATTN: KACY ARNOLD PHONE NO : 574-372-1644 56 EAST BELL DR. SE DECISION MADE: 02-DEC-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOVAD ZIRKON BIOMET, INC. 510(k) NO: K023327(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : P.O. BOX 587 SE DECISION MADE: 02-DEC-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NARROW ASCENT INTERLOK FEMORAL COMPONENTS BIOMET, INC. 510(k) NO: K024037(SPECIAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 30-DEC-02 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR BIOPLATE, INC. 510(k) NO: K023810(SPECIAL) ATTN: JUDY SOKUA PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 04-DEC-02 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS BIOTRONIK, INC. 510(k) NO: K023803(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 11-DEC-02 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS BORTEC BIOMEDICAL, LTD. 510(k) NO: K023147(TRADITIONAL) ATTN: CARL YOUNGMAN PHONE NO : 206-720-1540 936-11TH AVENUE EAST SE DECISION MADE: 12-DEC-02 SEATTLE, WA 98102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIMA BILIARY CATHETER BOSTON SCIENTIFIC/MEDI-TECH 510(k) NO: K023870(SPECIAL) ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 20-DEC-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKTOX MULTIPLE DRUG DIPCARD BRANAN MEDICAL CORP. 510(k) NO: K023489(SPECIAL) ATTN: CHIA HER PHONE NO : 949-598-7166 10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 16-DEC-02 IRVINE, CA 92618 510(k) STATEMENT DEVICE: SCOUT BOSS BURKE, INC. 510(k) NO: K023961(TRADITIONAL) ATTN: DUWAYNE E KRAMER JR. PHONE NO : 800-255-4147 1800 MERRIAM LANE SE DECISION MADE: 24-DEC-02 KANSAS CITY, KS 66106 510(k) STATEMENT DEVICE: GROSHONG NXT DUAL LUMEN PICC CATHETERS C.R. BARD, INC. 510(k) NO: K023374(ABBREVIATED) ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 18-DEC-02 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP. 510(k) NO: K023193(TRADITIONAL) ATTN: WILLIAM MCGRAIL PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 20-DEC-02 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CARDEON AEGIS CATHETER CARDEON CORP. 510(k) NO: K024058(SPECIAL) ATTN: JANE BEGGS PHONE NO : 408-253-3319 10161 BUBB RD. SE DECISION MADE: 30-DEC-02 CUPERTINO, CA 95014-4133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING CARDIOTECH INTL. 510(k) NO: K022584(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106 WEST 75TH LANE SE DECISION MADE: 30-DEC-02 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TULIP ALGINATE IMPRESSION MATERIAL CAVEX HOLLAND B.V. 510(k) NO: K023466(TRADITIONAL) ATTN: RICHARD WOORTMAN PHONE NO : 312 353 07763 PO BOX 852 SE DECISION MADE: 13-DEC-02 HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT DEVICE: REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH CENTER FOR BIOMATERIALS AND ADVANC510(k) NO: K023328(TRADITIONAL) ATTN: MELISSA MAHALL PHONE NO : 301-623-2500 11800 BALTIMORE AVE.NUE SE DECISION MADE: 12-DEC-02 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BELTSVILLE, MD 20705 DEVICE: VITAL SLIM CHATTANOOGA GROUP 510(k) NO: K023347(TRADITIONAL) ATTN: CHERYL BAGWELL PHONE NO : 423-870-7207 4717 ADAMS ROAD SE DECISION MADE: 06-DEC-02 HIXSON, TN 37343 510(k) STATEMENT DEVICE: CHEETAH I.V.D.S., MODEL 2002P CHEETAH MEDICAL INC. 510(k) NO: K023370(TRADITIONAL) ATTN: ARAVA HACOHEN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 24-DEC-02 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT CIBA VISION CORP. 510(k) NO: K023732(TRADITIONAL) ATTN: TERRINA WILDER PHONE NO : 678-415-3809 11460 JOHNS CREEK PKWY. SE DECISION MADE: 10-DEC-02 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COUL CLINIQA CORPORATION 510(k) NO: K023661(TRADITIONAL) ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900 1432 SOUTH MISSION ROAD SE DECISION MADE: 06-DEC-02 FALLBROOK, CA 92028 510(k) STATEMENT DEVICE: COALESCENT U-CLIP- AND ACCESSORIES COALESCENT SURGICAL 510(k) NO: K023125(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 408-743-9700 559 EAST WEDDELL DR. SE DECISION MADE: 18-DEC-02 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 COAPT SYSTEMS, INC. 510(k) NO: K023922(SPECIAL) ATTN: SHELLEY TRIMM PHONE NO : 707-545-7337 1152 NAVARRO STREET SE DECISION MADE: 20-DEC-02 SANTA ROSA, CA 95401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT AGILE SCOOTER, LY-EW303 COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K023581(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 528 92093 NO 58 FU-CHIUN ST. SE DECISION MADE: 02-DEC-02 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: ENHANCE HTF MEDIUM WITH HEPES CONCEPTION TECHNOLOGIES 510(k) NO: K023655(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 13-DEC-02 IRVINE, CA 92606 510(k) STATEMENT DEVICE: SPERM WASH MEDIUM WITH GENTAMICIN CONCEPTION TECHNOLOGIES 510(k) NO: K023717(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 6835 FLANDERS DR. SUITE 500 SE DECISION MADE: 13-DEC-02 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEV CONSOLIDATED TECHNOLOGY 510(k) NO: K023731(TRADITIONAL) ATTN: CANDICE BETZ PHONE NO : 512-445-5100 4401 FREIDRICH LANE BLDG 1 SE DECISION MADE: 24-DEC-02 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744-1832 DEVICE: CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR CONTAMAC LTD. 510(k) NO: K023349(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 24-DEC-02 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYDNEY IVF HYALURONIDASE COOK UROLOGICAL, INC. 510(k) NO: K023353(TRADITIONAL) ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500 1100 WEST MORGAN ST. SE DECISION MADE: 20-DEC-02 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED COOPER SURGICAL 510(k) NO: K023379(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 11-DEC-02 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPERSURGICAL MALLEABLE SYTLET COOPER SURGICAL 510(k) NO: K023382(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 20-DEC-02 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER COOPER SURGICAL 510(k) NO: K023383(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 13-DEC-02 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPERSURGICAL TRIAL TRANSFER CATHETER COOPER SURGICAL 510(k) NO: K023384(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 P.O. BOX 2156 SE DECISION MADE: 13-DEC-02 HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDI CORDIS CORP. 510(k) NO: K023907(SPECIAL) ATTN: DONNA MARSHALL PHONE NO : 908-412-3844 7 POWDER HORN DR. SE DECISION MADE: 18-DEC-02 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS, GATIFLOXACIN DADE BEHRING, INC. 510(k) NO: K023361(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD SE DECISION MADE: 16-DEC-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS ANTIMICROB DADE BEHRING, INC. 510(k) NO: K023541(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD SE DECISION MADE: 13-DEC-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNORE-AID MAX DENTAL IMAGINEERS, LLC 510(k) NO: K022284(TRADITIONAL) ATTN: WILLIAM A BELFER PHONE NO : 732-493-4747 804 WEST PARK AVE. SE DECISION MADE: 10-DEC-02 OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE VERSANAIL DEPUY ORTHOPAEDICS, INC. 510(k) NO: K023115(TRADITIONAL) ATTN: DINA L WEISSMAN, J.D. PHONE NO : 574-371-4905 700 ORTHOPAEDIC DR. SE DECISION MADE: 18-DEC-02 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER DEPUY ORTHOPAEDICS, INC. 510(k) NO: K023786(SPECIAL) ATTN: KARLA A HAM PHONE NO : 574-371-4925 700 ORTHOPAEDIC DR. SE DECISION MADE: 10-DEC-02 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM DEPUYACROMED 510(k) NO: K021039(TRADITIONAL) ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704 325 PARAMOUNT DRIVE SE DECISION MADE: 11-DEC-02 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K023330(TRADITIONAL) ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396 16 MCCARVILLE ST SE DECISION MADE: 11-DEC-02 CHARLOTTETOWN, PE, CANADA C1E2A6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K022713(TRADITIONAL) ATTN: JAMES L BROWN PHONE NO : 740-593-1784 350 WEST STATE STREET SE DECISION MADE: 18-DEC-02 ATHENS, OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 ALLERGEN-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K023152(ABBREVIATED) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 17-DEC-02 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K023304(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 09-DEC-02 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVLT KIT AND D15PLUS AND D30PLUS DIODE DIOMED, INC. 510(k) NO: K023543(TRADITIONAL) ATTN: SAMUEL D WADE PHONE NO : 978-475-7771 ONE DUNDEE PARK, SUITES 5&6 SE DECISION MADE: 02-DEC-02 PO BOX 97 510(k) SUMMARY AVAILABLE FROM FDA ANDOVER, MA 01810 DEVICE: EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P. 510(k) NO: K023233(TRADITIONAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 13-DEC-02 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE PHOTON ENERGY RECOVERY (PER) OPTION ELGEMS, LTD. 510(k) NO: K023932(TRADITIONAL) ATTN: HEMY NEUMAN PHONE NO : 972 485 63667 4 HAYOZMA ST., P.O. BOX 170 SE DECISION MADE: 11-DEC-02 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 ENDOCARE, INC. 510(k) NO: K023757(SPECIAL) ATTN: EBEN GORDON PHONE NO : 949-450-5424 201 TECHNOLOGY DR. SE DECISION MADE: 05-DEC-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D ERBE USA, INC. 510(k) NO: K023886(SPECIAL) ATTN: JOHN TARTAL PHONE NO : 770-955-4400 2225 NORTHWEST PARKWAY SE DECISION MADE: 12-DEC-02 MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE ETHICON, INC. 510(k) NO: K022715(TRADITIONAL) ATTN: REY LIBROJO PHONE NO : 908-218-3198 P.O. BOX 151 SE DECISION MADE: 19-DEC-02 SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER ETHICON, INC. 510(k) NO: K023880(SPECIAL) ATTN: PETER CECCHINI PHONE NO : 908-218-2457 ROUTE 22 WEST SE DECISION MADE: 11-DEC-02 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT EVENFLO COMPANY, INC. 510(k) NO: K022933(TRADITIONAL) ATTN: MATTHEW G MCCARTY PHONE NO : 937-415-3288 707 CROSSROADS COURT SE DECISION MADE: 02-DEC-02 VANDALIA, OH 45377 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPLORER POWERED WHEELCHAIR EVERMED CORP. 510(k) NO: K023485(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DRIVE SE DECISION MADE: 02-DEC-02 PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALAXY SERIES WHEELCHAIR EVERMED CORP. 510(k) NO: K023993(TRADITIONAL) ATTN: CALVIN CHANG PHONE NO : 714-777-9997 4999 E. LA PALMA AVE. SE DECISION MADE: 27-DEC-02 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENNIUM SERIES MANUAL WHEELCHAIRS EVERMED CORP. 510(k) NO: K024030(TRADITIONAL) ATTN: CALVIN CHANG PHONE NO : 714-777-9997 4999 E. LA PALMA AVE. SE DECISION MADE: 12-DEC-02 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXEL VACULET BLOOD COLLECTION SET EXELINT INTL. CO. 510(k) NO: K020533(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 WEST CENTINELA AVE. SE DECISION MADE: 02-DEC-02 LOS ANGELES, CA 90045 510(k) STATEMENT DEVICE: TUCKER EMBRYO CATHETER FERTILITY TECHNOLOGY RESOURCES, IN510(k) NO: K023017(TRADITIONAL) ATTN: THOMAS J ZINNANTI PHONE NO : 770-360-7778 4343 SHALLOWFORD ROAD SE DECISION MADE: 13-DEC-02 SUITE D-4 510(k) STATEMENT MARIETTA, GA 30062 DEVICE: FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRIN FISHER DIAGNOSTICS 510(k) NO: K023362(TRADITIONAL) ATTN: JERALD STEINER PHONE NO : 540-869-8382 8365 VALLEY PIKE SE DECISION MADE: 09-DEC-02 MIDDLETOWN, VA 22645-0307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM FOTONA D.D. 510(k) NO: K021548(TRADITIONAL) ATTN: MOJCA VALJAVEC PHONE NO : 386 1 5009114 STEGNE 7, SE DECISION MADE: 06-DEC-02 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K023241(TRADITIONAL) ATTN: M. FRANK LEWIS PHONE NO : 901-682-0417 6258 SHADY GROVE ROAD EAST SE DECISION MADE: 24-DEC-02 MEMPHIS, TN 38120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIZMO FREEDOM DESIGNS, INC. 510(k) NO: K023574(TRADITIONAL) ATTN: GINNY S MALOCO PHONE NO : 800-331-8551 2241 MADERA ROAD SE DECISION MADE: 04-DEC-02 SIMI VALLEY, CA 93065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE GE LUNAR CORP. 510(k) NO: K023554(TRADITIONAL) ATTN: JAMES P RASKOB PHONE NO : 608-826-7425 726 HEARTLAND TRAIL SE DECISION MADE: 20-DEC-02 MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEBAUER'S INSTANT ICE GEBAUER CO. 510(k) NO: K021726(TRADITIONAL) ATTN: SUZANNE B WOJCIK PHONE NO : 216-271-5252 9410 ST. CATHERINE AVE. SE DECISION MADE: 12-DEC-02 CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-WAVE ALTERMANS (TWA) ALGORITHM OPTION GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K023380(TRADITIONAL) ATTN: DAVID WAHLIG PHONE NO : 262-293-1705 8200 WEST TOWER AVE. SE DECISION MADE: 03-DEC-02 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMALGA PACS GLOBAL CARE SOLUTIONS, S.A. 510(k) NO: K023246(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 23-DEC-02 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILTRAC .035 PERIPHERAL DILATATION CATHETER GUIDANT CORP. 510(k) NO: K023320(TRADITIONAL) ATTN: MICHELLE GROSSMAN PHONE NO : 650-470-6372 1525 O'BRIEN DR. SE DECISION MADE: 10-DEC-02 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. 510(k) NO: K023007(TRADITIONAL) ATTN: RICHARD D BLISS PHONE NO : 954-385-1690 510 STONEMONT DRIVE SE DECISION MADE: 05-DEC-02 WESTON, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LTFS230 HEALTHTRONICS, INC. 510(k) NO: K021775(TRADITIONAL) ATTN: PETER WEIMAN PHONE NO : 770-419-0691 1841 WEST OAK PARKWAY SE DECISION MADE: 23-DEC-02 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 HELIX MEDICAL, INC. 510(k) NO: K023259(TRADITIONAL) ATTN: CYNTHIA M ANDERSON PHONE NO : 805-684-3305 1110 MARK AVE. SE DECISION MADE: 26-DEC-02 CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM HELP TECHNOLOGIES 510(k) NO: K023491(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-235-0545 24312 ARMADA DR. SE DECISION MADE: 13-DEC-02 DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K023784(SPECIAL) ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518 9033 RED BRANCH RD. SE DECISION MADE: 24-DEC-02 COLUMBIA, MD 21045 510(k) STATEMENT DEVICE: PAROS CRP HORIBA LTD. 510(k) NO: K022690(TRADITIONAL) ATTN: IAN GILES PHONE NO : 949-453-0500 34 BUNSEN DRIVE SE DECISION MADE: 23-DEC-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K022905(TRADITIONAL) ATTN: SCOTT MOELLER PHONE NO : 706-846-3126 1 HORIZON WAY SE DECISION MADE: 13-DEC-02 MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS HOVEROUND CORP. 510(k) NO: K022993(TRADITIONAL) ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 02-DEC-02 SARASOTA, FL 34243 510(k) STATEMENT DEVICE: GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) HOWMEDICA OSTEONICS CORP. 510(k) NO: K023087(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SE DECISION MADE: 16-DEC-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 SUPRACONDYLAR NAIL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K023267(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 11-DEC-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K024060(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 20-DEC-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS HUDSON DIAGNOSTIC IMAGING LLC 510(k) NO: K022928(TRADITIONAL) ATTN: MARTIN E WENDELKEN PHONE NO : 718-542-0472 610 BOULEVARD SE DECISION MADE: 11-DEC-02 ELMWOOD PARK, NJ 07407 510(k) STATEMENT DEVICE: MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K023938(SPECIAL) ATTN: THOMAS A DOLD PHONE NO : 320-587-1571 40 WEST HIGHLAND PARK SE DECISION MADE: 13-DEC-02 HUTCHINSON, MN 55350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA HYCOR BIOMEDICAL, INC. 510(k) NO: K022944(TRADITIONAL) ATTN: RANDY WILSON PHONE NO : 714-933-3000 7272 CHAPMAN AVE. SE DECISION MADE: 18-DEC-02 GARDEN GROVE, CA 92841 510(k) STATEMENT DEVICE: AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA HYCOR BIOMEDICAL, INC. 510(k) NO: K022945(TRADITIONAL) ATTN: RANDY WILSON PHONE NO : 714-933-3000 7272 CHAPMAN AVE. SE DECISION MADE: 18-DEC-02 GARDEN GROVE, CA 92841 510(k) STATEMENT DEVICE: HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5 HYGIA HEALTH SERVICES, INC. 510(k) NO: K021509(ABBREVIATED) ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670 2800 MILAN CT., SUITE 259 SE DECISION MADE: 24-DEC-02 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAGON INFUSION SYSTEM WITH BOLUS I-FLOW CORP. 510(k) NO: K023827(SPECIAL) ATTN: SHANE NOEHRE PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 13-DEC-02 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, I-FLOW CORP. 510(k) NO: K023883(SPECIAL) ATTN: SHANE NOEHRE PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 20-DEC-02 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPL IMPLANT INNOVATIONS, INC. 510(k) NO: K022009(TRADITIONAL) ATTN: JEANNETTE G DAILEY PHONE NO : 561-776-6913 4555 RIVERSIDE DR. SE DECISION MADE: 30-DEC-02 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE IMPLANT SCIENCES CORP. 510(k) NO: K023242(SPECIAL) ATTN: JEFFREY GIBBS PHONE NO : 781-246-0700 107 AUDUBON ROAD, #5 SE DECISION MADE: 04-DEC-02 WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULD IMPLEX CORP. 510(k) NO: K022377(TRADITIONAL) ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 10-DEC-02 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMTEC SENDAX MDI ORTHO6 AND ORTHO8 IMTEC CORP. 510(k) NO: K023067(TRADITIONAL) ATTN: BRAD VANCE PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 03-DEC-02 ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY T INNOVATECH, INC 510(k) NO: K023500(TRADITIONAL) ATTN: TONY C.S. CHANG PHONE NO : 886 422 972787 NO 5, ALLEY 5, SE DECISION MADE: 13-DEC-02 LANE CHENG HSING, CHUNG CHING 510(k) SUMMARY AVAILABLE FROM FDA PEI TUN DIST. TAICHUNG, CHINA (TAIWAN) DEVICE: HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVI INSTRUMENTATION LABORATORY CO. 510(k) NO: K023269(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 23-DEC-02 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPARETTE, MODEL LAP J L S H N INSTRUMENTS MEDICAUX G.B., INC. 510(k) NO: K022979(SPECIAL) ATTN: MARTIN PAQUETTE PHONE NO : 819 569 8717 1184 BLVD. ALEXANDRE SE DECISION MADE: 18-DEC-02 SHERBROOKE, QUEBEC, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL AMI1200 C-ARM INTEGRITY PRACTICE MANAGEMENT, INC510(k) NO: K022911(TRADITIONAL) ATTN: KEVIN J MEURET PHONE NO : 1104 ENTERPRISE DRIVE SE DECISION MADE: 02-DEC-02 SIOUX FALLS, SD 57106 510(k) STATEMENT DEVICE: INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (O INTERPORE CROSS INTL. 510(k) NO: K022048(TRADITIONAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 04-DEC-02 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSITIONAL IMPLANTS INTRA-LOCK INTERNATIONAL 510(k) NO: K021915(ABBREVIATED) ATTN: JEFFREY SAKOFF PHONE NO : 561-447-8282 1200 N. FEDERAL HWY SUITE#200 SE DECISION MADE: 19-DEC-02 BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 INVITROCARE, INC. 510(k) NO: K023222(TRADITIONAL) ATTN: ROBERT E LOVINS PHONE NO : 858-792-1311 11760-H SORRENTO VALLEY RD SE DECISION MADE: 26-DEC-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIM-V (R) MEDIUM, MODEL 087-0112 INVITROGEN CORPORATION 510(k) NO: K022086(TRADITIONAL) ATTN: KEITH D GITTERMAN PHONE NO : 716-774-6713 3175 STALEY RD. SE DECISION MADE: 23-DEC-02 GRAND ISLAND, NY 14072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER IVOCLAR VIVADENT, INC. 510(k) NO: K023035(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 02-DEC-02 AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTA PORT J. MORITA MFG. CORP. 510(k) NO: K022147(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K STREET N.W. SE DECISION MADE: 20-DEC-02 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-50 JOHARI DIGITAL HEALTHCARE, LTD. 510(k) NO: K024036(SPECIAL) ATTN: NISHA JOHARI PHONE NO : 912 912 430028 EC-1,2, 3 ELECTRONIC COMPLEX SE DECISION MADE: 20-DEC-02 LIGHT INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA JODHPUR, RAJ, INDIA 342003 DEVICE: JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000 JOMED, INC. 510(k) NO: K022762(TRADITIONAL) ATTN: TERRY SCHULTZ PHONE NO : 858-673-0189 15330 AVE. OF SCIENCE, SE DECISION MADE: 16-DEC-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92128 DEVICE: JOSTRA MECC SYSTEM JOSTRA AG 510(k) NO: K023132(TRADITIONAL) ATTN: KATHLEEN JOHNSON PHONE NO : 800-955-4236 2828 N. CRESCENT RIDGE DR. SE DECISION MADE: 17-DEC-02 THE WOODLANDS, TX 77381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY LP(A) CONTROLS KAMIYA BIOMEDICAL CO. 510(k) NO: K023853(TRADITIONAL) ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 13-DEC-02 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: KSEA SPINOSCOPE KARL STORZ ENDOSCOPY 510(k) NO: K023187(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 02-DEC-02 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA DEPLOYABLE CARDIOVASCULAR CLAMP KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K014277(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 11-DEC-02 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEGELMASTER 2000 KEGELMASTER 2000 LTD. 510(k) NO: K023305(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 26-DEC-02 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUUM ASSISTED CLOSURE KINETIC CONCEPTS, INC. 510(k) NO: K021500(TRADITIONAL) ATTN: WILLIAM H QUIRK PHONE NO : 210-255-4468 P.O. BOX 659508 SE DECISION MADE: 20-DEC-02 SAN ANTONIO, TX 78265-9508 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT KINETIC CONCEPTS, INC. 510(k) NO: K021501(TRADITIONAL) ATTN: WILLIAM H QUIRK PHONE NO : 210-255-4468 P.O. BOX 659508 SE DECISION MADE: 02-DEC-02 SAN ANTONIO, TX 78265-9508 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYS KINETIKOS MEDICAL, INC. 510(k) NO: K023770(SPECIAL) ATTN: JOHN SPAMPINATO PHONE NO : 858-558-2233 4115 SORRENTO VALLEY ROAD SE DECISION MADE: 12-DEC-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K024025(TRADITIONAL) ATTN: JAMES F LOGAN PHONE NO : 410-837-1751 1301 DEFENSE HIGHWAY SE DECISION MADE: 18-DEC-02 GAMBRILLS, MD 21054 510(k) STATEMENT DEVICE: ECHO SOUNDER, ES-102EX KOVEN TECHNOLOGY, INC. 510(k) NO: K023143(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 19-DEC-02 HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX HRI DIGITAL RADIOGRAPHY SYSTEM KRUGMAN TECHNOLOGIES, INC 510(k) NO: K023292(TRADITIONAL) ATTN: MICHAEL A KRUGMAN PHONE NO : 800-506-9736 1000 HART ROAD SE DECISION MADE: 13-DEC-02 SUITE 180 510(k) SUMMARY AVAILABLE FROM FDA BARRINGTON, IL 60010 DEVICE: HA ORBITAL IMPLANT LABORATOIRE VILLANOVA 510(k) NO: K021643(TRADITIONAL) ATTN: ISABELLE DRUBAIX PHONE NO : 33 3 21056423 RESIDENCE BLUE MARINE SE DECISION MADE: 13-DEC-02 65 RUE LEON GARET 510(k) SUMMARY AVAILABLE FROM FDA LE TOUQUET, FRANCE F62520 DEVICE: SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. 510(k) NO: K023832(SPECIAL) ATTN: JOHN E HUGHES PHONE NO : 408-942-5903 1000 GIBRALTAR DR. SE DECISION MADE: 13-DEC-02 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUBEAM, SUPER NOVA, DIO LIGHT FORCE THERAPY, INC. 510(k) NO: K022888(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 11-DEC-02 BOULDER, CO 80301 510(k) STATEMENT DEVICE: SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K023316(TRADITIONAL) ATTN: CHIU CHIN CHANG PHONE NO : 408-732-3856 687 NORTH PASTORIA AVENUE SE DECISION MADE: 16-DEC-02 SYNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METHADONE ENZYME IMMUNOASSAY LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K023317(TRADITIONAL) ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360 2391 ZANKER RD., SUITE 340 SE DECISION MADE: 12-DEC-02 SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTEL 1 FOLDER IMPLANTATION SYSTEM MASTEL PRECISION, INC. 510(k) NO: K022723(TRADITIONAL) ATTN: MAUREEN WEINER PHONE NO : 949-757-0755 53 BARCELONA SE DECISION MADE: 26-DEC-02 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INF MCKINLEY INFUSER 510(k) NO: K023098(TRADITIONAL) ATTN: JOHN CHAPPELL PHONE NO : 303-514-0665 631 HOWARD #202 SE DECISION MADE: 09-DEC-02 SAN FRANCISCO, CA 94105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O.B. TAMPONS MCNEIL-PPC, INC. 510(k) NO: K023789(SPECIAL) ATTN: DIANA L.B. UHL PHONE NO : 908-874-1700 199 GRANDVIEW RD. SE DECISION MADE: 06-DEC-02 SKILLMAN, NJ 08558-9498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 MED-TEC,INC. 510(k) NO: K023293(TRADITIONAL) ATTN: DONALD F RIIBE PHONE NO : 712-737-8688 1401 8TH STREET S.E. SE DECISION MADE: 23-DEC-02 P.O. BOX 320 510(k) STATEMENT ORANGE CITY, IA 51041 DEVICE: MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL MEDICAL ADVANCES, INC. 510(k) NO: K023084(TRADITIONAL) ATTN: ANTHONY DIETZLER PHONE NO : 414-258-3808 10437 INNOVATION DR. SE DECISION MADE: 16-DEC-02 MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONT MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K023669(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 19-DEC-02 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K023867(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 17-DEC-02 CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED U MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K023928(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 11-DEC-02 CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR RED MEDICAL BIO CARE SWEDEN AB 510(k) NO: K023081(TRADITIONAL) ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616 908 STETSON STREET SE DECISION MADE: 16-DEC-02 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFANT/CHILD REDUCED ENERGY ELECTRODES MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K022732(TRADITIONAL) ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332 11811 WILLOWS RD., N.E. SE DECISION MADE: 13-DEC-02 REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K014296(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 10-DEC-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K023415(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 13-DEC-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAURAIN DEWALD ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K023797(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 13-DEC-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELI MEDTRONIC, INC. 510(k) NO: K024032(SPECIAL) ATTN: LYNN JENSEN PHONE NO : 763-514-4459 7000 CENTRAL AVENUE NE SE DECISION MADE: 30-DEC-02 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY MEDTRONIC, INC. 510(k) NO: K024035(SPECIAL) ATTN: LYNN JENSEN PHONE NO : 763-514-4459 7000 CENTRAL AVENUE NE SE DECISION MADE: 30-DEC-02 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. 510(k) NO: K023798(SPECIAL) ATTN: ASHER KASSEL PHONE NO : 972 8 9323333 4 HAYARDEN ST., YAVNE SE DECISION MADE: 03-DEC-02 P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA REHOVOT, ISRAEL 76100 DEVICE: A1CNOW FOR HOME USE METRIKA, INC. 510(k) NO: K022661(TRADITIONAL) ATTN: ERIKA B AMMIRATI PHONE NO : 408-524-2255 510 OAKMEAD PKWY. SE DECISION MADE: 13-DEC-02 SUNNYVALE, CA 94085-4022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KERATOME BLADE 200200 & 600600 MICROSPECIALTIES, INC. 510(k) NO: K020482(TRADITIONAL) ATTN: CHARLES VASSALLO PHONE NO : 203-874-1832 264 QUARRY RD. SE DECISION MADE: 16-DEC-02 MILFORD, CT 06478 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITEK PDS/PGA STAPLE MITEK WORLDWIDE 510(k) NO: K021953(TRADITIONAL) ATTN: PETRA C SMIT PHONE NO : 781-251-3196 249 VANDERBILT AVENUE SE DECISION MADE: 20-DEC-02 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM MITEK WORLDWIDE 510(k) NO: K023388(SPECIAL) ATTN: PETRA C SMIT PHONE NO : 781-251-3196 249 VANDERBILT AVENUE SE DECISION MADE: 27-DEC-02 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAUM-LECTRIC MRI DRILLING MACHINE MRI DEVICES DAUM GMBH 510(k) NO: K021098(TRADITIONAL) ATTN: E. J SMITH PHONE NO : 410-451-0639 P.O. BOX 4331 SE DECISION MADE: 03-DEC-02 CROFTON,, MD 21114 510(k) STATEMENT DEVICE: GYNEFLEX NAISSANCE HOLDINGS, LC 510(k) NO: K021115(TRADITIONAL) ATTN: NANCY E TAYLOR PHONE NO : 202-331-3100 800 CONNECTICUT AVENUE, N.W. SE DECISION MADE: 20-DEC-02 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: MODIFICATION TO NANMA VACUUM PUMP NANMA MFG CO., LTD. 510(k) NO: K013113(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 20-DEC-02 CROFTON, MD 21114 510(k) STATEMENT DEVICE: BIOLOY NEIRYNCK & VOGT NV 510(k) NO: K023477(TRADITIONAL) ATTN: JOSH ANDRACHEK PHONE NO : 614-577-1945 12960 STONECREEK DRIVE SE DECISION MADE: 13-DEC-02 SUITE C 510(k) STATEMENT PICKERINGTON, OH 43147 DEVICE: NEW STAR LASERS, INC. "DOVE" ND: YAG LASER SYSTEM, MODEL: NS-160 NEW STAR LASERS, INC. 510(k) NO: K023962(SPECIAL) ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 24-DEC-02 ROSEVILLE, CA 95747 510(k) STATEMENT DEVICE: NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE NICORE EQUIPMENT & LEASING, INC. 510(k) NO: K023016(TRADITIONAL) ATTN: JEFF MOGILEWICZ PHONE NO : 813-901-0019 4897 W. WATERS AVE., SUITE J SE DECISION MADE: 04-DEC-02 TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MP-1 MICRO PERIMETER NIDEK TECHNOLOGIES SRL 510(k) NO: K023719(TRADITIONAL) ATTN: ALDO COCCHIGLIA PHONE NO : 394 989 35191 VIA REGIA, 88 SE DECISION MADE: 23-DEC-02 VIGONZA (PADOVA), ITALY 35010 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE NINGBO TIANSHUN RUBBER PRODUCTS CO510(k) NO: K023702(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 18-DEC-02 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT PROFILE PHOX PLUS L ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K023567(ABBREVIATED) ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 20-DEC-02 WALTHAM, MA 02454-9141 510(k) STATEMENT DEVICE: NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. 510(k) NO: K014152(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION STREET SE DECISION MADE: 11-DEC-02 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843 DEVICE: OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K023077(TRADITIONAL) ATTN: DEANNA WERBER PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 10-DEC-02 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSO OLYMPUS OPTICAL CO., LTD. 510(k) NO: K023280(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 19-DEC-02 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTJF-160AF DUODENOVIDEOSCOPE OLYMPUS OPTICAL CO., LTD. 510(k) NO: K024033(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 20-DEC-02 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS OMRON HEALTHCARE, INC. 510(k) NO: K021682(TRADITIONAL) ATTN: IWAO KOJIMA PHONE NO : 847-680-6200 300 LAKEVIEW PKWY. SE DECISION MADE: 12-DEC-02 VERNON HILLS, IL 60061 510(k) STATEMENT DEVICE: NON-BIOABSORBABLE STAPLE ONUX MEDICAL, INC. 510(k) NO: K023372(TRADITIONAL) ATTN: RUTHANN DEPIETRO PHONE NO : 603-929-6200 5 MERRILL DR. SE DECISION MADE: 27-DEC-02 HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION D ORION DIAGNOSTICA, DIV. ORION CORP510(k) NO: K022176(TRADITIONAL) ATTN: ANNIKKA RANTAMA PHONE NO : 358 10 4292736 KOIVU-MANKKAAN TIE 6 SE DECISION MADE: 03-DEC-02 ESPOO, FINLAND 02200 510(k) STATEMENT DEVICE: VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS C ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K023875(SPECIAL) ATTN: MARLENE A HANNA PHONE NO : 585-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 10-DEC-02 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CA ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K023876(SPECIAL) ATTN: MARLENE A HANNA PHONE NO : 585-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 10-DEC-02 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLD CORE 35 PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K023501(TRADITIONAL) ATTN: GREG JIMMIE PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 18-DEC-02 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JEWEL CAST PLUS PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K023502(TRADITIONAL) ATTN: GREG JIMMIE PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 18-DEC-02 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP PHILIPS MEDICAL SYSTEMS 510(k) NO: K023871(SPECIAL) ATTN: DAVID OSBORN PHONE NO : 978-659-3178 3000 MINUTEMAN RD. SE DECISION MADE: 04-DEC-02 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS EASYVISION WORKSTATION RELEASE 6 PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K023137(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 19-DEC-02 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 DEVICE: Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PL PHILIPS ULTRASOUND, INC. 510(k) NO: K023877(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 23-DEC-02 BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTI-SNORING DEVICE OR "ASD" PI MEDICAL 510(k) NO: K011723(TRADITIONAL) ATTN: LINDA S ALEXANDER PHONE NO : 763-287-3830 4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 18-DEC-02 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE PLUS ORTHOPEDICS 510(k) NO: K023667(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 24-DEC-02 ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D PNEU PAC, LTD. 510(k) NO: K020899(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100 SMITHS MEDICAL SE DECISION MADE: 13-DEC-02 N7 W22025 JOHNSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53186-1856 DEVICE: AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) POINTE SCIENTIFIC, INC. 510(k) NO: K023396(TRADITIONAL) ATTN: RON JAMISON PHONE NO : 313-383-7220 1025 JOHN A. PAPALAS DR. SE DECISION MADE: 23-DEC-02 LINCOLN PARK, MI 48146 510(k) STATEMENT DEVICE: PEDIATRIC ARTERIAL CANNULA POLYSTAN A/S 510(k) NO: K023251(TRADITIONAL) ATTN: DANA OLSEN PHONE NO : 45 44 651566 WALGERHOLM 8 SE DECISION MADE: 04-DEC-02 VAERLOSE, DENMARK DK-3500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VAS POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K022313(TRADITIONAL) ATTN: BARBARA J WHITMAN PHONE NO : 215-862-4450 110 UNION SQUARE DR. SE DECISION MADE: 09-DEC-02 NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K023700(SPECIAL) ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1736 2405 WEST ORTON CIR. SE DECISION MADE: 04-DEC-02 WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRAPULSE PRIMARY TECHNOLOGY, LLC. 510(k) NO: K022607(TRADITIONAL) ATTN: STEPHEN ALMEIDA PHONE NO : 813-288-0260 813 S. WESTSHORE BLVD. SE DECISION MADE: 20-DEC-02 TAMPA, FL 33609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 PROBLEM SOLVING CONCEPTS, INC. 510(k) NO: K023112(TRADITIONAL) ATTN: THOMAS M MCCLELLAND PHONE NO : 317-594-7431 8020 CASTLEWAY DR, SUITE 120 SE DECISION MADE: 17-DEC-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY SITE TISSUE MARKER DEVICE PROMEX, INC. 510(k) NO: K023450(TRADITIONAL) ATTN: JOSEPH L MARK PHONE NO : 317-736-0128 3049 HUDSON ST. SE DECISION MADE: 19-DEC-02 FRANKLIN, IN 46131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAUTERINE DELIVERY SYSTEM - INJECTOR PROSURG, INC. 510(k) NO: K023051(TRADITIONAL) ATTN: ASHVIN DESAI PHONE NO : 408-945-4044 2193 TRADE ZONE BLVD. SE DECISION MADE: 12-DEC-02 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE PURITAN BENNETT CORP. 510(k) NO: K023225(ABBREVIATED) ATTN: GINA TO PHONE NO : 925-463-4427 4280 HACIENDA DR. SE DECISION MADE: 18-DEC-02 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRIDIS OPHTHALMIC PHOTOCOAGULATOR QUANTEL MEDICAL 510(k) NO: K023094(TRADITIONAL) ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY ROAD SE DECISION MADE: 17-DEC-02 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMOSTOP FEMORAL COMPRESSION SYSTEM RADI MEDICAL SYSTEMS AB 510(k) NO: K024107(SPECIAL) ATTN: MATS GRANLUND PHONE NO : 461 816 1000 PALMBLADSGATAN 10 SE DECISION MADE: 24-DEC-02 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K022914(TRADITIONAL) ATTN: BRETT L NETHERTON PHONE NO : 803-926-8080 2013 WINDSOR DRIVE SE DECISION MADE: 20-DEC-02 CAYCE, SC 29033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY RITA MEDICAL SYSTEMS 510(k) NO: K023846(SPECIAL) ATTN: KAREN FRISCHMEYER PHONE NO : 650-314-3400 967 NORTH SHORELINE BLVD. SE DECISION MADE: 06-DEC-02 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOME CARE JELLY ROC CHINESE-EUROPEAN INDUSTRIAL RE510(k) NO: K022494(TRADITIONAL) ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918 2064 TAMARIN DR. SE DECISION MADE: 02-DEC-02 COLUMBUS, OH 43235 510(k) STATEMENT DEVICE: J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT ROC CHINESE-EUROPEAN INDUSTRIAL RE510(k) NO: K022518(TRADITIONAL) ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918 2064 TAMARIN DR. SE DECISION MADE: 02-DEC-02 COLUMBUS, OH 43235 510(k) STATEMENT DEVICE: ONLINE DAT II COCAINE II ROCHE DIAGNOSTICS CORP. 510(k) NO: K023281(TRADITIONAL) ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 06-DEC-02 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K024098(SPECIAL) ATTN: SHERRI L COENEN PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 19-DEC-02 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K022500(TRADITIONAL) ATTN: DONALD DANALD PHONE NO : 248-960-9009 30142 WIXOM ROAD SE DECISION MADE: 23-DEC-02 WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA-LITE 200E LIGHT CURE UNIT ROLENCE ENT. INC. 510(k) NO: K023545(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 3 4631999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 30-DEC-02 CHUNGLI, CHINA (TAIWAN) 320 510(k) STATEMENT DEVICE: ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M ROLOR ELECTRONICS CORP. 510(k) NO: K020130(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 02-DEC-02 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: SANIDAD TENS-DUO MODE GP8016N ROLOR ELECTRONICS CORP. 510(k) NO: K021430(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN ST. SE DECISION MADE: 02-DEC-02 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: RUSCH MICROLARYNGEAL TUBE RUSCH INTL. 510(k) NO: K023964(TRADITIONAL) ATTN: RICK LYKINS PHONE NO : 603-532-0204 50 PLANTATION DRIVE SE DECISION MADE: 23-DEC-02 JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY S&S; PAR SCIENTIFIC 510(k) NO: K021987(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 27-DEC-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: SAS BLOOD/SERUM/URINE/URINE HCG SA SCIENTIFIC, INC. 510(k) NO: K022683(TRADITIONAL) ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800 4919 GOLDEN QUAIL SE DECISION MADE: 16-DEC-02 SAN ANTONIO, TX 78240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFILE 1320 LASER SYSTEM SCITON, INC. 510(k) NO: K022466(TRADITIONAL) ATTN: JAY M PATAL PHONE NO : 650-493-9155 845 COMMERCIAL STREET SE DECISION MADE: 31-DEC-02 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAU SENORX, INC. 510(k) NO: K023923(SPECIAL) ATTN: AMY BOUCLY PHONE NO : 949-362-4800 11 COLUMBIA, SUITE A SE DECISION MADE: 11-DEC-02 ALISO VIEJO, CA 92656 510(k) STATEMENT DEVICE: MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K020837(TRADITIONAL) ATTN: TONY T.K. CHENG PHONE NO : 86 21 59799888 NO.6318, FANG HUANG RD, HUAXIN SE DECISION MADE: 02-DEC-02 QINGPU, SHANGHAI, CHINA 201708 510(k) STATEMENT DEVICE: ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K023560(TRADITIONAL) ATTN: DANNY WANG PHONE NO : 862 157 727722 #1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 17-DEC-02 SONGJIANG SHANGHAI, CHINA 201600 510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER SHANGHAI PM PLASTICS ENTERISE CO.,510(k) NO: K024026(TRADITIONAL) ATTN: CHANG TE SUN PHONE NO : 011 86 2157814212 258 YUSHU RD. SE DECISION MADE: 18-DEC-02 CANGQIAO TOWNSHIP 510(k) STATEMENT SHONGJIANG COUNTY, SHANGHAI, CHINA 201600 DEVICE: NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER C SIAM SEMPERMED CORP. LTD. 510(k) NO: K024106(TRADITIONAL) ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250 30798 US HWY 19 NORTH SE DECISION MADE: 20-DEC-02 PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER C SIAM SEMPERMED CORP. LTD. 510(k) NO: K024121(ABBREVIATED) ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250 30798 US HWY 19 NORTH SE DECISION MADE: 20-DEC-02 PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K024108(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 18-DEC-02 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWCOR SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K020440(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4779 186 WOOD AVENUE SOUTH SE DECISION MADE: 03-DEC-02 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SST SALIVA SUPPORTING TABLETS SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K023046(TRADITIONAL) ATTN: DENISE SWIFT PHONE NO : 44 148 3428611 BOROUGH RD. SE DECISION MADE: 02-DEC-02 GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X SINTEA BIOTECH, INC. 510(k) NO: K020085(TRADITIONAL) ATTN: MARIANNE GRUNWALDT PHONE NO : 305-673-6226 407 LINCOLN RD. SUITE 10L SE DECISION MADE: 10-DEC-02 MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE SMART PRACTICE 510(k) NO: K023232(TRADITIONAL) ATTN: KIM SULLIVAN PHONE NO : 602-225-9090 3400 EAST MCDOWELL ROAD SE DECISION MADE: 11-DEC-02 PHOENIX, AZ 85008 510(k) STATEMENT DEVICE: SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICA SMITH & NEPHEW, INC. 510(k) NO: K021798(ABBREVIATED) ATTN: GINO J ROUSS PHONE NO : 901-399-6707 1450 E. BROOKS ROAD SE DECISION MADE: 09-DEC-02 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFLECTION CONSTRAINED LINER SMITH & NEPHEW, INC. 510(k) NO: K021803(ABBREVIATED) ATTN: JANET JOHNSON GREEN PHONE NO : 901-399-5153 1450 E. BROOKS ROAD SE DECISION MADE: 19-DEC-02 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) SONOSITE,INC. 510(k) NO: K023957(TRADITIONAL) ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297 21919 30TH DRIVE SE. SE DECISION MADE: 12-DEC-02 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOVIS OPTIQUE'S ENDOSCOPIC CABLE SOVIS OPTIQUE 510(k) NO: K023633(TRADITIONAL) ATTN: FRANCES K WU PHONE NO : 202-737-4294 700 THIRTEENTH STREET NW SE DECISION MADE: 31-DEC-02 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: SPECTRUM CERVICAL SPINAL SYSTEM SPINAL INNOVATIONS, LLC. 510(k) NO: K022997(TRADITIONAL) ATTN: JOSEPH S CLIFT PHONE NO : 901-373-8855 7850 STAGE HILLS BLVD. SE DECISION MADE: 06-DEC-02 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BARTLETT, TN 38133-4029 DEVICE: SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP SPS MEDICAL SUPPLY CORP. 510(k) NO: K023716(SPECIAL) ATTN: GARY J SOCOLA PHONE NO : 585-359-0130 6789 WEST HENRIETTA RD. SE DECISION MADE: 05-DEC-02 RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SICKLE-CHEX SOLUBILITY KIT STRECK LABORATORIES, INC. 510(k) NO: K023656(TRADITIONAL) ATTN: CAROL THOMPSON PHONE NO : 402-537-5313 7002 SOUTH 109TH ST. SE DECISION MADE: 30-DEC-02 LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL CMF SYSTEM STRYKER INSTRUMENTS 510(k) NO: K022185(TRADITIONAL) ATTN: WADE T RUTKOSKIE PHONE NO : 616-323-4226 4100 EAST MILHAM AVENUE SE DECISION MADE: 17-DEC-02 KALAMAZOO, MI 49087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 SULZER CARBOMEDICS, INC. 510(k) NO: K023185(TRADITIONAL) ATTN: TEFFANY HANKINSON PHONE NO : 512-435-3202 1300 EAST ANDERSON LN. SE DECISION MADE: 17-DEC-02 AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPO SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K023243(SPECIAL) ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018 651 CAMPUS DR. SE DECISION MADE: 13-DEC-02 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENDENT ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. 510(k) NO: K022985(TRADITIONAL) ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306 9900 SPECTRUM DR. SE DECISION MADE: 05-DEC-02 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AN SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K024011(TRADITIONAL) ATTN: MARY ANN BARKER PHONE NO : 541-549-4164 723 CURTIS CT; PO BOX 2060 SE DECISION MADE: 19-DEC-02 SISTERS, OR 97759 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER SYNTHES (USA) 510(k) NO: K023862(SPECIAL) ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 19-DEC-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES TANGSHAN ZHONGHONG PULIN FOOD PROD510(k) NO: K022091(TRADITIONAL) ATTN: DAVID HU PHONE NO : 510-477-9631 33235 TRANSIT AVENUE SE DECISION MADE: 30-DEC-02 UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 TAUT, INC. 510(k) NO: K023261(TRADITIONAL) ATTN: MAX CLOAT PHONE NO : 630-232-2507 2571 KANEVILLE COURT SE DECISION MADE: 13-DEC-02 GENEVA, IL 60134 510(k) STATEMENT DEVICE: SCOOTER MARS SERIES, MODEL TL-588 TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K022698(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-DEC-02 HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: NIGHTRON POLYSOMNOGRAPHY SYSTEM TELEDIAGNOSTIC SYSTEMS, INC. 510(k) NO: K022249(TRADITIONAL) ATTN: LARRY WOODARD PHONE NO : 800-277-3224 1757 EAST BAYSHORE RD., #24 SE DECISION MADE: 31-DEC-02 REDWOOD CITY, CA 94063 510(k) STATEMENT DEVICE: TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP. 510(k) NO: K023271(ABBREVIATED) ATTN: SANDI LARTKA PHONE NO : 410-392-7243 950 ELKTON BLVD. SE DECISION MADE: 18-DEC-02 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE ASPIRATION NEEDLE NA-200H THE OLYMPUS OPTICAL CO. 510(k) NO: K023272(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE DRIVE SE DECISION MADE: 23-DEC-02 MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TILITE EVO TISPORT, LLC 510(k) NO: K024055(TRADITIONAL) ATTN: RICHARD S FOREMAN PHONE NO : 509-586-6117 1426 EAST THIRD AVE. SE DECISION MADE: 20-DEC-02 KENNEWICK, WA 99337-9669 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIA-PACK CA 19-9 TOSOH CORP. 510(k) NO: K023239(TRADITIONAL) ATTN: JUDITH E LOEBEL PHONE NO : 203-881-1032 73 COGWHEEL LANE SE DECISION MADE: 23-DEC-02 SEYMOUR, CT 06483 510(k) STATEMENT DEVICE: ST AIA-PACK CA 19-9 TOSOH CORP. 510(k) NO: K023240(TRADITIONAL) ATTN: JUDITH E LOEBEL PHONE NO : 203-881-1032 73 COGWHEEL LANE SE DECISION MADE: 23-DEC-02 SEYMOUR, CT 06483 510(k) STATEMENT DEVICE: ST AIA-PACK TESTOSTERONE ASSAY TOSOH MEDICS, INC. 510(k) NO: K023091(TRADITIONAL) ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 17-DEC-02 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SOUTH SAN FRANCISCO, CA 94080 DEVICE: ST AIA-PACK CA 125 ENZYME IMMUNOASSAY TOSOH MEDICS, INC. 510(k) NO: K023891(SPECIAL) ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 06-DEC-02 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SOUTH SAN FRANCISCO, CA 94080 DEVICE: ST AIA-PACK CEA ENZYME IMMUNOASSAY TOSOH MEDICS, INC. 510(k) NO: K023893(SPECIAL) ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 18-DEC-02 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SOUTH SAN FRANCISCO, CA 94080 DEVICE: ST AIA-PACK AFP ENZYME IMMUNOASSAY TOSOH MEDICS, INC. 510(k) NO: K023894(SPECIAL) ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970 347 OYSTER POINT BLVD., SE DECISION MADE: 17-DEC-02 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SOUTH SAN FRANCISCO, CA 94080 DEVICE: TRANSONIC SYRINGE WARMER, MODEL SYR-1000 TRANSONIC SYSTEMS, INC. 510(k) NO: K022963(TRADITIONAL) ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300 34 DUTCH MILL RD. SE DECISION MADE: 04-DEC-02 ITHACA, NY 14850-9787 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BURETTE-IN LINE (150 ML) TUTA HEALTHCARE PTY LIMITED 510(k) NO: K023595(TRADITIONAL) ATTN: OMID SOURESRAFIL PHONE NO : 612 942 70300 318-332 BURNS BAY ROAD SE DECISION MADE: 18-DEC-02 LANE COVE 510(k) SUMMARY AVAILABLE FROM FDA SYDNEY NSW, AUSTRALIA 2066 DEVICE: USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY U-SYSTEMS, INC. 510(k) NO: K022517(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 24-DEC-02 LOS ALTOS,, CA 94204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIDUS MALE LATEX CONDOM UNIDUS CORP. 510(k) NO: K023059(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 12-DEC-02 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) UNIDUS CORP. 510(k) NO: K023129(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 13-DEC-02 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) UNIDUS CORP. 510(k) NO: K023175(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 13-DEC-02 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNDUS MALE LATEX CONDOM (WITH FLAVORING) UNIDUS CORP. 510(k) NO: K023176(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 13-DEC-02 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHAMPION 5000 PERIPHERAL VASCULAR COIL USA INSTRUMENTS, INC. 510(k) NO: K023247(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 23-DEC-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VALUMED 510(k) NO: K023539(TRADITIONAL) ATTN: THOMAS E COTTONE PHONE NO : 850-897-3321 1439 LIVE OAK STREET SE DECISION MADE: 17-DEC-02 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA NICEVILLE, FL 32578 DEVICE: VANGUARD REPROCESSED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K022780(TRADITIONAL) ATTN: MIKE SAMMON PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 11-DEC-02 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K023180(TRADITIONAL) ATTN: MIKE SAMMON PHONE NO : 863-904-1628 5307 GREAT OAK DR. SE DECISION MADE: 12-DEC-02 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K023154(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949-488-8700 32236- E PASEO ADELANTO SE DECISION MADE: 20-DEC-02 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER VASCULAR ONE, INC. 510(k) NO: K022028(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 17-DEC-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 VICTUS, INC. 510(k) NO: K023469(TRADITIONAL) ATTN: ILEANA YANES PHONE NO : 305-663-2129 4918 S.W. 74 CT. SE DECISION MADE: 10-DEC-02 MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERMGRAD, MODELS 10022/10063 VITROLIFE SWEDEN AB 510(k) NO: K023403(TRADITIONAL) ATTN: NINA ARVIDSSON PHONE NO : 463 172 18000 MOLNDALSVAGEN 30 SE DECISION MADE: 13-DEC-02 GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 VOMED VOLZER MEDIZINTECHNIK GMBH &510(k) NO: K023019(TRADITIONAL) ATTN: DAGMAR MASER PHONE NO : 828-622-7572 152B BRIDGE STREET SE DECISION MADE: 10-DEC-02 HOT SPRINGS, NC 28743 510(k) STATEMENT DEVICE: VIABIL BILIARY ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC 510(k) NO: K014215(TRADITIONAL) ATTN: JACQUELINE KALBACH PHONE NO : 928-864-3731 3450 WEST KILTIE LANE SE DECISION MADE: 19-DEC-02 FLAGSTAFF,, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VIABAHN ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC 510(k) NO: K023811(SPECIAL) ATTN: TIMOTHY J RYNN PHONE NO : 928-864-3714 3750 WEST KILTIE LANE SE DECISION MADE: 10-DEC-02 P.O. BOX 900 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ 86002-0900 DEVICE: W.O.M. LASER U100 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K023041(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617-868-3995 91 TROWBRIDGE STREET SE DECISION MADE: 11-DEC-02 CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKSET MIMIX BONE VOID FILLER WALTER LORENZ SURGICAL, INC. 510(k) NO: K023718(SPECIAL) ATTN: KACY ARNOLD PHONE NO : 574-372-1644 56 EAST BELL DRIVE SE DECISION MADE: 04-DEC-02 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581 DEVICE: THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS WELL-LIFE HEALTHCARE, INC. 510(k) NO: K020020(TRADITIONAL) ATTN: TONY C CHANG PHONE NO : 886 422 9724776 NO. 5 ALLEY 5 LANE CHENG HSING SE DECISION MADE: 30-DEC-02 CHUNG CHING RD., PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) DEVICE: PORTA GEO TI WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K023389(TRADITIONAL) ATTN: RUDOLF WAGNER PHONE NO : 497 231 37050 SCHWENNINGER STRASSE 13 SE DECISION MADE: 06-DEC-02 PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPORTA G WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K023391(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 497 231 3507219 SCHWENNINGER STRABE 13 SE DECISION MADE: 10-DEC-02 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGC SPECIAL ALLOY WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K023392(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 497 231 3507219 SCHWENNINGER STRABE 13 SE DECISION MADE: 06-DEC-02 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTADUR P2 WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K023395(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 497 231 3507219 SCHWENNINGER STRABE 13 SE DECISION MADE: 11-DEC-02 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB AMILASA 405 AA LIQUIDA WIENER LABORATORIES S.A.I.C. 510(k) NO: K023549(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191 2944 RIOBAMBA SE DECISION MADE: 09-DEC-02 ROSARIO, SANTA FE, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA WIENER LABORATORIES S.A.I.C. 510(k) NO: K023550(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191 2944 RIOBAMBA SE DECISION MADE: 09-DEC-02 ROSARIO, SANTA FE, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB GOT (AST) UV AA LIQUIDA WIENER LABORATORIES S.A.I.C. 510(k) NO: K023551(TRADITIONAL) ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191 2944 RIOBAMBA SE DECISION MADE: 09-DEC-02 ROSARIO, SANTA FE, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPIPHYSIS LIMB SALVAGE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K021489(TRADITIONAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 04-DEC-02 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STE WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K023517(SPECIAL) ATTN: TERENCE LIM PHONE NO : 603 870 61486 LOT 1, JALAN 3, SE DECISION MADE: 02-DEC-02 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERI WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K024130(SPECIAL) ATTN: TERENCE LIN PHONE NO : 60 3 87061486 LOT 1, JALAN 3, SE DECISION MADE: 30-DEC-02 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: PREG-Q EARLY PREGNANCY TEST YD DIAGNOSTICS 510(k) NO: K023027(TRADITIONAL) ATTN: ART BEACH PHONE NO : 813-649-0855 962 ALLEGRO LANE SE DECISION MADE: 16-DEC-02 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORE YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K023577(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 06-DEC-02 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER LINUX Z-KAT, INC. 510(k) NO: K023975(SPECIAL) ATTN: CHRISTINA VANCE PHONE NO : 954-927-2044 2903 SIMMS STREET SE DECISION MADE: 20-DEC-02 HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCCLUFAST ROCK ZHERMACK S.P.A. 510(k) NO: K024034(SPECIAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 18-DEC-02 BEND, OR 97702 510(k) STATEMENT DEVICE: ZETAPLUS SOFT ZHERMACK S.P.A. 510(k) NO: K024041(SPECIAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 18-DEC-02 BEND, OR 97702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES ZIMMER, INC. 510(k) NO: K021826(TRADITIONAL) ATTN: KAREN CAIN PHONE NO : 574-372-4219 P.O. BOX 708 SE DECISION MADE: 20-DEC-02 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 321 TOTAL WITH SUMMARIES 270 TOTAL WITH STATEMENTS 51
Updated 01/06/2003
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