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Medical Devices
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December 2002 510(k) Clearances
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 S 510(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
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