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510(k)s Final Decisions Rendered for June 2002 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JUN-2002 THROUGH 30-JUN-2002 DEVICE: ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE AB BIODISK 510(k) NO: K021445(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760 DALVAGEN 10 SE DECISION MADE: 06-JUN-02 SOLNA, SWEDEN 16956 510(k) STATEMENT DEVICE: ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) ACCUMETRICS, INC. 510(k) NO: K012701(TRADITIONAL) ATTN: RHONDA MOE PHONE NO : 858-404-8238 3985 SORRENTO VALLEY BLVD SE DECISION MADE: 12-JUN-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSICIAN'S DESKTOP REVIEW ADAC LABORATORIES 510(k) NO: K021669(TRADITIONAL) ATTN: COLEEN COLEMAN PHONE NO : 408-468-3051 540 ALDER DR. SE DECISION MADE: 05-JUN-02 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PAINDOC ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K021518(SPECIAL) ATTN: RASHMI MOZA PHONE NO : 972-309-8055 6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 06-JUN-02 PLANO, TX 75024 510(k) STATEMENT DEVICE: ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL ADVANCED ORTHOPAEDIC SOLUTIONS 510(k) NO: K021008(TRADITIONAL) ATTN: PAUL DONER PHONE NO : 310-831-4433 333 WEST 6TH ST., SUITE 202 SE DECISION MADE: 20-JUN-02 SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMI REPROCESSED MULTIPLE CLIP APPLIERS (NON-RELOADABLE) ADVEN MEDICAL 510(k) NO: K012690(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 26-JUN-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED USED, DISPOSABLE CUTTERS, STAPLERS AND APPLIERS ADVEN MEDICAL 510(k) NO: K012697(TRADITIONAL) ATTN: MARK W ALDANA PHONE NO : 806-745-7718 1001 SLATON HWY. SE DECISION MADE: 26-JUN-02 LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K021423(ABBREVIATED) ATTN: NAISHU WANG PHONE NO : 858-513-3888 12330 STOWE DRIVE SE DECISION MADE: 17-JUN-02 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL CORP. 510(k) NO: K012623(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 24-JUN-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED EBI EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. 510(k) NO: K012645(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51ST. STREET SE DECISION MADE: 24-JUN-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. 510(k) NO: K012648(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51ST. STREET SE DECISION MADE: 24-JUN-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL, INC. 510(k) NO: K012634(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 480-763-5300 10232 SOUTH 51 STREET SE DECISION MADE: 24-JUN-02 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MOD ALTUS MEDICAL, INC. 510(k) NO: K014040(TRADITIONAL) ATTN: KATHY MAYNOR PHONE NO : 650-259-5586 821 COWAN RD. SE DECISION MADE: 03-JUN-02 BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILMSAVER, NT VERSION 5.03 AMERICAN MEDICAL RESOURCES, LTD. (510(k) NO: K021072(TRADITIONAL) ATTN: ELIZABETH N FAULSTICH PHONE NO : 302-477-0276 3501 SILVERSIDE ROAD SUITE 205 SE DECISION MADE: 06-JUN-02 WILMINGTON, DE 19810 510(k) STATEMENT DEVICE: OXYGEN TREATMENT HOOD AMRON INTERNATIONAL DIVING SUPPLY,510(k) NO: K011592(TRADITIONAL) ATTN: NORMA F OCKWIG PHONE NO : 760-746-3834 759 WEST FOURTH AVE SE DECISION MADE: 19-JUN-02 ESCONDIDO, CA 92025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANIMUS EZSERTER INFUSION SET INSERTER ANIMAS CORP. 510(k) NO: K021700(TRADITIONAL) ATTN: RICHARD MICHELIN PHONE NO : 610-644-8990 590 E. LANCASTER AVENUE SE DECISION MADE: 04-JUN-02 FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: APEX MEDICAL DIGITAL EMS TS1311, TS1312 APEX MEDICAL CORP. 510(k) NO: K021754(SPECIAL) ATTN: ALAN CHANG PHONE NO : 886 2 26954122 10TH FL., NO. 31, LANE 169, SE DECISION MADE: 28-JUN-02 KANG NING ST., HSI-CHIH CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: APEX MEDICAL DIGITAL TENS TS1211, TS1212 APEX MEDICAL CORP. 510(k) NO: K021755(SPECIAL) ATTN: ALAN CHANG PHONE NO : 886 2 26954122 10TH FL., NO. 31, LANE 169, SE DECISION MADE: 12-JUN-02 KANG NING ST., HSI-CHIH CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 APOTHECARY PRODUCTS, INC. 510(k) NO: K020296(TRADITIONAL) ATTN: GREG LARSON PHONE NO : 952-890-1940 11750 12TH AVE. SOUTH SE DECISION MADE: 25-JUN-02 BURNSVILLE, MN 55337-1295 510(k) STATEMENT DEVICE: SURE STEP COC II DRUG SCREEN TEST (DIPSTICK) APPLIED BIOTECH, INC. 510(k) NO: K021785(SPECIAL) ATTN: STEVE WORCESTER PHONE NO : 858-587-6771 10237 FLANDERS CT. SE DECISION MADE: 13-JUN-02 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K021412(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 622 166 20201 195 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 07-JUN-02 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SEN ARROW INTL., INC. 510(k) NO: K021462(SPECIAL) ATTN: WILLIAM PAQUIN PHONE NO : 617-389-6400 9 PLYMOUTH ST. SE DECISION MADE: 06-JUN-02 EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 ARROW INTL., INC. 510(k) NO: K021567(TRADITIONAL) ATTN: WILLIAM G MCLAIN PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 19-JUN-02 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER COR ARTHROCARE CORP. 510(k) NO: K021519(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 06-JUN-02 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSATOME EXCELLUS MICROKERATOME BAUSCH & LOMB, INC. 510(k) NO: K021640(SPECIAL) ATTN: DENNIS POZZO PHONE NO : 636-226-3183 3365 TREE CT. INDUSTRIAL BLVD. SE DECISION MADE: 19-JUN-02 ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUPLOREACH BAXTER HEALTHCARE CORP. 510(k) NO: K014088(TRADITIONAL) ATTN: ARLENE VIDOR PHONE NO : 818-507-5523 550 N. BRAND BLVD. SE DECISION MADE: 07-JUN-02 GLENDALE, CA 91203-1900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML BAXTER HEALTHCARE CORP. 510(k) NO: K020666(ABBREVIATED) ATTN: ARLENE VIDOR PHONE NO : 818-507-5523 550 N. BRAND BLVD. SE DECISION MADE: 24-JUN-02 GLENDALE, CA 91203-1900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR BAYER DIAGNOSTICS CORP. 510(k) NO: K021532(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 27-JUN-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR BAYER DIAGNOSTICS CORP. 510(k) NO: K021535(TRADITIONAL) ATTN: KENNETH T EDDS PHONE NO : 914-524-2446 511 BENEDICT AVE SE DECISION MADE: 27-JUN-02 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR BCI, INC. 510(k) NO: K020739(TRADITIONAL) ATTN: DONALD J ALEXANDER PHONE NO : 262-542-3100 N7 W22025 JOHNSON ROAD SE DECISION MADE: 03-JUN-02 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER CELLPREP BECKMAN COULTER, INC. 510(k) NO: K021150(TRADITIONAL) ATTN: LOURDES COBA PHONE NO : 305-380-4079 11800 SW 147TH AVENUE SE DECISION MADE: 11-JUN-02 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SY BECKMAN COULTER, INC. 510(k) NO: K021229(TRADITIONAL) ATTN: BRUCE BACKLUND PHONE NO : 952-368-1611 1000 LAKE HAZELTINE DR. SE DECISION MADE: 28-JUN-02 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTR BECTON DICKINSON INFUSION THERAPY 510(k) NO: K020834(TRADITIONAL) ATTN: LASLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE ST. SE DECISION MADE: 12-JUN-02 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS BIO-LOGIC SYSTEMS CORP. 510(k) NO: K021801(SPECIAL) ATTN: NORMAN E BRUNNER PHONE NO : 847-949-5200 ONE BIO-LOGIC PLAZA SE DECISION MADE: 27-JUN-02 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 BIOLITEC, INC. 510(k) NO: K020835(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 12-JUN-02 WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCIGEN-S BONE VOID FILER BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013790(TRADITIONAL) ATTN: PATRICIA S BERES PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 11-JUN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEMENTED FEMORAL HEAD RESURFING DEVICE BIOMET ORTHOPEDICS, , INC. 510(k) NO: K021799(SPECIAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 26-JUN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDUCED SIZE ONCOLOGY SALVAGE SYSTEM BIOMET, INC. 510(k) NO: K021260(TRADITIONAL) ATTN: SARA B SHULTZ PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 05-JUN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT ALL-POLY PS TIBIAL BEARINGS BIOMET, INC. 510(k) NO: K021559(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 05-JUN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXED BEARING UNI COMPONENT BIOMET, INC. 510(k) NO: K021621(SPECIAL) ATTN: DALENE T BINKLY PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 05-JUN-02 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER BIOMET, INC. 510(k) NO: K021832(SPECIAL) ATTN: SARA B SHULTZ PHONE NO : 574-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 26-JUN-02 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MEDICA EASYQC HEMATOCRIT CONTROL BIONOSTICS, INC. 510(k) NO: K021924(TRADITIONAL) ATTN: KATHY STORRO PHONE NO : 978-772-7070 7 JACKSON ROAD SE DECISION MADE: 24-JUN-02 DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL BIONOSTICS, INC. 510(k) NO: K021930(TRADITIONAL) ATTN: KATHY STORRO PHONE NO : 978-772-7070 7 JACKSON ROAD SE DECISION MADE: 25-JUN-02 DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET SUTURE ANCHOR BIONX IMPLANTS, LTD. 510(k) NO: K020056(TRADITIONAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 P.O. BOX 3 SE DECISION MADE: 26-JUN-02 HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA TAMPERE, FINLAND FIN-33720 DEVICE: THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILL BIOPLATE, INC. 510(k) NO: K021684(TRADITIONAL) ATTN: CAROL E JONES PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 26-JUN-02 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 BIOSITE INCORPORATED 510(k) NO: K014247(TRADITIONAL) ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 03-JUN-02 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 BIOTRONIK, INC. 510(k) NO: K020821(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 03-JUN-02 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM BLUE SKY BIO 510(k) NO: K021833(SPECIAL) ATTN: ALBERT ZICKMANN PHONE NO : 773-769-2622 5455 N. SHERIDAN ROAD SE DECISION MADE: 10-JUN-02 #3608 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60640 DEVICE: EQUALIZER BALLOON CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K021721(SPECIAL) ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 20-JUN-02 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 BOSTON SCIENTIFIC, TARGET 510(k) NO: K021494(SPECIAL) ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 06-JUN-02 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M3 (MICRO-MULTILEAF COLLIMATOR) BRAINLAB AG 510(k) NO: K020860(TRADITIONAL) ATTN: STEFAN VILSMEIER PHONE NO : 498 999 15680 AMMERTHALSTRASSE 8 SE DECISION MADE: 06-JUN-02 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSIOLOG, SERIES 95000 CAMTRONICS, LTD. 510(k) NO: K013032(TRADITIONAL) ATTN: SCOTT J PEASE PHONE NO : 262-367-0700 900 WALNUT RIDGE DRIVE SE DECISION MADE: 04-JUN-02 HARTLAND, WI 53029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA CBEAM PULSED DYE LASER SYSTEM CANDELA CORP. 510(k) NO: K020958(TRADITIONAL) ATTN: LORRAINE NELSON PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 21-JUN-02 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOGLOBIN A1C CONTROL CANTERBURY SCIENTIFIC 510(k) NO: K021484(TRADITIONAL) ATTN: MAURICE OWEN PHONE NO : 643 355 5598 21 WROXTON TERRACE SE DECISION MADE: 14-JUN-02 CHRISTCHURCH, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMMATRIX SURGICAL MESH CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K021160(TRADITIONAL) ATTN: KAREN E PETERSON PHONE NO : 651-762-2146 1290 HAMMOND RD. SE DECISION MADE: 12-JUN-02 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDEON AEGIS CATHETER CARDEON CORP. 510(k) NO: K013593(TRADITIONAL) ATTN: JANE BEGGS PHONE NO : 408-517-2522 10161 BUBB RD. SE DECISION MADE: 24-JUN-02 CUPERTINO, CA 95014-4133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE ALT CARESIDE, INC. 510(k) NO: K020487(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 04-JUN-02 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUCAM CARL ZEISS OPHTHALMIC SYSTEMS, INC510(k) NO: K021787(SPECIAL) ATTN: DIONNE N LABATORE PHONE NO : 202-637-5794 555 THIREENTH STREET, N.W. SE DECISION MADE: 21-JUN-02 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAXCEL PICC WITH PASV VALVE TECHNOLOGY CATHETER INNOVATIONS, INC. 510(k) NO: K021704(SPECIAL) ATTN: ROGER L RICHINS PHONE NO : 801-954-8444 3598 WEST 1820 SOUTH SE DECISION MADE: 06-JUN-02 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEFAR MEDICAL AB CEFAR PRIMO CEFAR MEDICAL AB 510(k) NO: K020803(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 10-JUN-02 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARE CARIOVASCULAR PATCH CHASE MEDICAL, INC. 510(k) NO: K021129(TRADITIONAL) ATTN: DAVE HERNON PHONE NO : 972-783-0644 1710 FIRMAN DRIVE SE DECISION MADE: 03-JUN-02 SUITE 100 510(k) STATEMENT RICHARDSON, TX 75081 DEVICE: SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATI CHF SOLUTIONS, INC. 510(k) NO: K013733(TRADITIONAL) ATTN: DIANNA THOMSEN PHONE NO : 202-626-5594 1730 PENNSYLVANIA AVE., N.W. SE DECISION MADE: 03-JUN-02 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTENSION SET LIGHT-SAFE, MODEL BC565 CODAN US CORP. 510(k) NO: K021480(TRADITIONAL) ATTN: MARILYN R POURAZAR PHONE NO : 800-332-6326 3511 WEST SUNFLOWER AVE. SE DECISION MADE: 27-JUN-02 SANTA ANA, CA 92704-6944 510(k) STATEMENT DEVICE: BODY FORCE, MODEL BT 6000 COMPOSITES SOLUTIONS, INC. 510(k) NO: K020211(TRADITIONAL) ATTN: RANDY SISK PHONE NO : 803-233-0043 1940 OLD DUNBAR ROAD SE DECISION MADE: 28-JUN-02 WEST COLUMBIA, SC 29172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED HEATWAVE HAND-CONTROLLED ELETRODE CONMED CORP. 510(k) NO: K021299(TRADITIONAL) ATTN: IRA D DUESLER PHONE NO : 315-624-3072 525 FRENCH RD. SE DECISION MADE: 26-JUN-02 UTICA, NY 13502 510(k) STATEMENT DEVICE: ABSORBENT ANTIMICROBIAL WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K013814(TRADITIONAL) ATTN: DEMETRIOS KYDONIEUS PHONE NO : 908-904-2537 200 HEADQUARTERS PARK DR. SE DECISION MADE: 21-JUN-02 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISIS GUIDED TISSUE REGENERATION MATRIX COOK BIOTECH, INC. 510(k) NO: K010952(TRADITIONAL) ATTN: MARK BLEYER PHONE NO : 765-497-3355 3055 KENT AVE. SE DECISION MADE: 10-JUN-02 WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YEL COPIOUMED INTL., INC. 510(k) NO: K021743(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 10-JUN-02 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT CORDIS CORP. 510(k) NO: K021345(SPECIAL) ATTN: KAREN WILK PHONE NO : 908-412-7446 7 POWDERHORN DRIVE SE DECISION MADE: 28-JUN-02 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENVOY AND VISTA BRITE TIP CORDIS CORP. 510(k) NO: K021593(SPECIAL) ATTN: STEPHEN M ENOS PHONE NO : 786-313-2402 14201 N.W. 60TH AVE. SE DECISION MADE: 13-JUN-02 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS CORONET GROUP NORTH AMERICA, LLC. 510(k) NO: K020776(TRADITIONAL) ATTN: THOMAS E FERARI PHONE NO : 518-792-2258 181 DIXION ROAD SE DECISION MADE: 03-JUN-02 QUEENSBURY,, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHA DADE BEHRING, , INC. 510(k) NO: K020410(TRADITIONAL) ATTN: MAUREEN MENDE PHONE NO : 916-374-3174 1584 ENTERPRISE BLVD SE DECISION MADE: 11-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 DADE BEHRING, INC. 510(k) NO: K020979(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 P.O. BOX 6101 SE DECISION MADE: 27-JUN-02 NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION TPSA CALIBRATOR, MODEL #RC459 DADE BEHRING, INC. 510(k) NO: K020980(TRADITIONAL) ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 RT. 896, GLASCOW BLDG. 500 SE DECISION MADE: 21-JUN-02 NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 DADE BEHRING, INC. 510(k) NO: K021381(TRADITIONAL) ATTN: DONNA A WOLF PHONE NO : 302-631-0384 514 GBC DRIVE SE DECISION MADE: 10-JUN-02 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM DADE MICROSCAN, INC. 510(k) NO: K020938(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 03-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL DADE MICROSCAN, INC. 510(k) NO: K021018(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 11-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN DADE MICROSCAN, INC. 510(k) NO: K021078(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 06-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE DADE MICROSCAN, INC. 510(k) NO: K021110(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 06-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME DADE MICROSCAN, INC. 510(k) NO: K021111(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 06-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTREP PLUS PANEL, AZITHROMYCIN DADE MICROSCAN, INC. 510(k) NO: K021169(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 06-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN DADE MICROSCAN, INC. 510(k) NO: K021181(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 17-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN DADE MICROSCAN, INC. 510(k) NO: K021184(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 20-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME DADE MICROSCAN, INC. 510(k) NO: K021188(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 06-JUN-02 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLA DEFIBTECH LLC 510(k) NO: K013896(TRADITIONAL) ATTN: GINTARAS VAISNYS PHONE NO : 203-453-6654 1200 BOSTON POST ROAD SE DECISION MADE: 19-JUN-02 SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA GUILFORD, CT 06437 DEVICE: PORTABLE HDX INTRAORAL X-RAY DEN-TAL-EZ, INC. 510(k) NO: K021378(TRADITIONAL) ATTN: DEON BECK PHONE NO : 717-291-1161 1816 COLONIAL VILLAGE LN. SE DECISION MADE: 07-JUN-02 LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) DEPUY ACROMED 510(k) NO: K021879(SPECIAL) ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 26-JUN-02 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) DEPUY ACROMED 510(k) NO: K021880(SPECIAL) ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 26-JUN-02 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEROYAL SURGICAL, UMBILICUP DEROYAL 510(k) NO: K020753(TRADITIONAL) ATTN: AUDREY DANIELS PHONE NO : 865-362-1373 200 DEBUSK LANE SE DECISION MADE: 13-JUN-02 POWELL, TN 37849 510(k) STATEMENT DEVICE: ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K021257(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 03-JUN-02 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM EBI, L.P. 510(k) NO: K021695(SPECIAL) ATTN: PATRICIA M FLOOD PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 20-JUN-02 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K021598(SPECIAL) ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 902 543 6665 2 COOK RD. SE DECISION MADE: 10-JUN-02 BRIDGEWATER, NOVA SCOTIA, CANADA B510(k) STATEMENT DEVICE: 300 PV COMPLETE ELECTROTHERAPY SYSTEM EMPI 510(k) NO: K021100(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 18-JUN-02 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICONDYLAR KNEE ENCORE ORTHOPEDICS, INC. 510(k) NO: K020741(TRADITIONAL) ATTN: JOANNA DROEGE PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 04-JUN-02 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDIUS ATAVI SYSTEM ENDIUS, INC. 510(k) NO: K021748(SPECIAL) ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 26-JUN-02 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE ENDOCARE, INC. 510(k) NO: K021010(SPECIAL) ATTN: EBEN GORDON PHONE NO : 949-595-5424 7 STUDEBAKER SE DECISION MADE: 06-JUN-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER ENVIRONMENTAL TECTONICS CORP. 510(k) NO: K020974(TRADITIONAL) ATTN: MICHAEL W ALLEN PHONE NO : 215-355-9100 125 JAMES WAY SE DECISION MADE: 26-JUN-02 SOUTHAMPTON, PA 18966-3877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-IMAGE DIGITAL X-RAY SYSTEM ESCAPE TECHNOLOGY, INC. 510(k) NO: K020588(TRADITIONAL) ATTN: JAY CHOI PHONE NO : 323-720-3100 1530 BEACH STREET SE DECISION MADE: 13-JUN-02 MONTEBELLO, CA 90640 510(k) STATEMENT DEVICE: PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS ETHICON ENDO-SURGERY, INC. 510(k) NO: K020779(TRADITIONAL) ATTN: DOUG KENTZ PHONE NO : 513-337-8699 4545 CREEK RD. SE DECISION MADE: 05-JUN-02 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL EXACTECH, INC. 510(k) NO: K021715(SPECIAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 12-JUN-02 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOPATH FAXITRON X-RAY CORP. 510(k) NO: K021113(TRADITIONAL) ATTN: SAMIR B PALIWAL PHONE NO : 303-450-4304 225 LARKIN DR.,SUITE 1 SE DECISION MADE: 13-JUN-02 WHEELING, IL 60090 510(k) STATEMENT DEVICE: ECHO-SCREEN T, TA, TD, TDA, TC FISCHER-ZOTH AUDIOLOGIC SYSTEMS, I510(k) NO: K013977(TRADITIONAL) ATTN: MICHAEL SOERENSEN PHONE NO : 801-541-4017 1257 WEST MARGARET VIEW CIRCLE SE DECISION MADE: 14-JUN-02 RIVERTON, UT 84065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOREX CORPORATION, OPTIMA, SPINAL SYSTEM FOREX CORP. 510(k) NO: K020279(TRADITIONAL) ATTN: ROBERT MALONE PHONE NO : 801-262-3100 6132 SOUTH 380 WEST, SUITE 200 SE DECISION MADE: 20-JUN-02 MURRAY, UT 84107-6988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT FOSSA INDUSTRIES, INC. 510(k) NO: K021140(TRADITIONAL) ATTN: GLORIA KOLB PHONE NO : 617-275-7481 580 HARRISON AVE., SE DECISION MADE: 28-JUN-02 4TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA BOSTON, MA 02118 DEVICE: ESOP CO-CR FEMORAL HEADS FOURNITURES HOSPITALIERES 510(k) NO: K021109(TRADITIONAL) ATTN: ANDRE WEITH PHONE NO : 202-835-1346 C/O PHARMANET, INC. SE DECISION MADE: 12-JUN-02 815 CONNECTICUT AVE NW STE 800 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: TITANIUM CANNULATED INTERFERENCE SCREW FUTURE MEDICAL SYSTEMS, INC. 510(k) NO: K021030(TRADITIONAL) ATTN: PATRICK JANIN PHONE NO : 410-761-9411 504 MCCORMICK DR. SE DECISION MADE: 25-JUN-02 GLEN BURNIE, MD 21061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMX-4 PLUS MOBILE X-RAY SYSTEM GE MEDICAL SYSTEMS 510(k) NO: K021016(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 17-JUN-02 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WORKBENCH BYGENX INTL., INC. 510(k) NO: K020560(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700 393 SOUNDVIEW ROAD SE DECISION MADE: 19-JUN-02 GUILFORD, CT 06437 510(k) STATEMENT DEVICE: "COTTONY" II, "SILKY" II POLYDEK & TEVDEK II POLYESTER SUTURE GENZYME CORP. 510(k) NO: K021019(TRADITIONAL) ATTN: MARY GRAY PHONE NO : 508-677-6600 600 AIRPORT ROAD SE DECISION MADE: 18-JUN-02 FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT GETINGE/CASTLE, INC. 510(k) NO: K020205(TRADITIONAL) ATTN: MARK N SMITH PHONE NO : 716-272-5274 1777 EAST HENRIETTA RD. SE DECISION MADE: 24-JUN-02 ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE GLORMED INTL., INC. 510(k) NO: K021353(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-9550 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 06-JUN-02 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRPEK-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 GOOD BIOTECH CORP. 510(k) NO: K020603(TRADITIONAL) ATTN: VICTOR CHIOU PHONE NO : 886 4 23596873 38, 34TH RD. SE DECISION MADE: 13-JUN-02 TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG CITY, CHINA DEVICE: GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC GRAMS AMERICAN SUTURE, , INC. 510(k) NO: K021043(TRADITIONAL) ATTN: ANTHONY J DIMERCURIO PHONE NO : 262-375-0227 2225 DAKOTA DRIVE SE DECISION MADE: 21-JUN-02 GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAKAO SNARE II AND NAKAO SNARE III GRANIT MEDICAL INNOVATIONS 510(k) NO: K020891(TRADITIONAL) ATTN: NAOMI L NAKAO PHONE NO : 212-772-7100 992 FIFTH AVE. SE DECISION MADE: 17-JUN-02 NEW YORK, NY 10028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BMN "I" TYPE MARROW ASPIRATION NEEDLE H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K020987(TRADITIONAL) ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671 10147 UMBERLAND PLACE SE DECISION MADE: 25-JUN-02 BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDGEM HEALTHETECH, INC. 510(k) NO: K021605(SPECIAL) ATTN: GLENN M THIBAULT PHONE NO : 303-526-5085 523 PARK POINT DR. SE DECISION MADE: 14-JUN-02 GOLDEN, CO 80401 510(k) STATEMENT DEVICE: HORIZONS HOT BIOPSY FORCEPS HORIZONS INTL. CORP. 510(k) NO: K021706(TRADITIONAL) ATTN: RAFIC SALEH PHONE NO : 787-842-4000 287 MONTERREY ST. SE DECISION MADE: 21-JUN-02 PONCE, PR 00717 510(k) STATEMENT DEVICE: OMEGA II SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K020772(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 05-JUN-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCORPIO INSET PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. 510(k) NO: K020830(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SE DECISION MADE: 06-JUN-02 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K021744(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 59 ROUTE 17 SE DECISION MADE: 26-JUN-02 ALLENDALE, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIE HYPERBARIC TECHNOLOGIES, INC. 510(k) NO: K011866(ABBREVIATED) ATTN: DAVE HEANEY PHONE NO : 888-699-4325 3224 HOOVER AVE. SE DECISION MADE: 06-JUN-02 NATIONAL CITY, CA 91950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPERION VISIQUANT ANA TEST KIT HYPERION, INC. 510(k) NO: K013213(TRADITIONAL) ATTN: RADHA GOOLABSINGH PHONE NO : 305-238-3020 14100 S.W. 136TH ST. SE DECISION MADE: 04-JUN-02 MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NLITE SYSTEM,MODEL A00-1051 ICN PHOTONICS LTD. 510(k) NO: K020729(TRADITIONAL) ATTN: IAN MORTIMER PHONE NO : 441 554 755444 UNITS 1 & 2,HEOL RHOSYN SE DECISION MADE: 04-JUN-02 DAFEN PARC 510(k) SUMMARY AVAILABLE FROM FDA LLANELLI, CARMARTHENSHIRE, UNITED KINGDOM SA14 8QG DEVICE: BLOOD-PRESSURE METER IDT TECHNOLOGY LIMITED 510(k) NO: K021252(TRADITIONAL) ATTN: LILY LI PHONE NO : 852 276 47873 BLOCK C, 9/F., KAISER ESTATE, SE DECISION MADE: 17-JUN-02 PHASE 1, 41 MAN YUE STREET 510(k) STATEMENT HUNGHOM, HONG KONG DEVICE: IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DA IGEL VISION CARE PTE LTD. 510(k) NO: K020855(TRADITIONAL) ATTN: DEBBIE MCINTIRE PHONE NO : 209-612-4130 201 KING ARTHUR COURT SE DECISION MADE: 04-JUN-02 TRACY, CA 95376 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOLESTEROL 1, 2, 3 IMI 510(k) NO: K014018(TRADITIONAL) ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076 16809 BRIARDALE ROAD SE DECISION MADE: 24-JUN-02 ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURE RELINE/PICKUP MATERIAL IMTEC CORP. 510(k) NO: K021586(TRADITIONAL) ATTN: BRAD VANCE PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 14-JUN-02 ARDMORE, OK 73401 510(k) STATEMENT DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 INTUITIVE SURGICAL, INC. 510(k) NO: K021036(TRADITIONAL) ATTN: DAVID CASAL PHONE NO : 408-523-2113 950 KIFER ROAD SE DECISION MADE: 26-JUN-02 SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 INVACARE CORP. 510(k) NO: K021680(TRADITIONAL) ATTN: RAE ANN FARROW PHONE NO : 440-329-6000 ONE INVACARE WAY SE DECISION MADE: 18-JUN-02 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: SLEEP PAT 200 DEVICE ITAMAR MEDICAL (C.M.) 1997 LTD. 510(k) NO: K010156(TRADITIONAL) ATTN: GEORGE H MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SE DECISION MADE: 19-JUN-02 HASBROUCK HEIGHTS, NJ 07604 510(k) STATEMENT DEVICE: LEESPEC DISPOSABLE VAGINAL SPECULUM ITL CORPORATION, PTY LTD. 510(k) NO: K021017(TRADITIONAL) ATTN: WILLIAM L MOBBS PHONE NO : 61 2 62808535 41-45 TENNANT STREET SE DECISION MADE: 19-JUN-02 FYSHWICK, CANBERRA ACT, AUSTRALIA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFB (ABSORBABLE FOAM BUTTRESS) J&J CORPORATE BIOMATERIALS CENTER 510(k) NO: K014183(TRADITIONAL) ATTN: DAVID A DALESSANDRO PHONE NO : 908-218-2041 RT. 22 WEST, P.O. BOX 151 SE DECISION MADE: 12-JUN-02 SOMEVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY J. MORITA USA, INC. 510(k) NO: K021372(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 601 13TH STREET, N.W. SE DECISION MADE: 07-JUN-02 SUITE 500 NORTH 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: KSEA NEUROENDOSCOPES AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K021050(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 26-JUN-02 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAVO QUATTROCARE KAVO AMERICA 510(k) NO: K012308(TRADITIONAL) ATTN: JOHN WESTERMEIER PHONE NO : 847-550-6800 340 EAST MAIN STREET SE DECISION MADE: 26-JUN-02 LAKE ZURICH, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIPRO KINAMED, INC. 510(k) NO: K020764(TRADITIONAL) ATTN: VINEET K SARIN PHONE NO : 805-384-2748 820 FLYNN ROAD SE DECISION MADE: 03-JUN-02 CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL SA PRIMER KURARAY MEDICAL INC. 510(k) NO: K021427(TRADITIONAL) ATTN: MASAYA SASAKI PHONE NO : 212-986-2230 101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 07-JUN-02 NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. 510(k) NO: K021943(TRADITIONAL) ATTN: JOHN E HUGHES PHONE NO : 408-942-5903 1000 GIBRALTAR DR. SE DECISION MADE: 28-JUN-02 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGEL OF WATER COLON HYDROTHERAPY SYSTEM LIFESTREAM PURFICATION SYSTEMS, LL510(k) NO: K003720(TRADITIONAL) ATTN: RICHARD A HAMER PHONE NO : 817-294-3644 6401 MEADOWS WEST DR. SE DECISION MADE: 27-JUN-02 FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATAL LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K020368(TRADITIONAL) ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360 2391 ZANKER RD., SUITE 340 SE DECISION MADE: 04-JUN-02 SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K020395(TRADITIONAL) ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360 2391 ZANKER RD., SUITE 340 SE DECISION MADE: 04-JUN-02 SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K021449(TRADITIONAL) ATTN: CHIN CHIN CHANG PHONE NO : 408-944-0360 2391 ZANKER RD., SUITE 340 SE DECISION MADE: 18-JUN-02 SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSCREW XTRALOK LINVATEC CORP. 510(k) NO: K013131(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BOULEVARD SE DECISION MADE: 11-JUN-02 LARGO, FL 34643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARKNEW PRODUCTS ACUPUNCTURE NEEDLES MARKNEW PRODUCTS 510(k) NO: K020880(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE, SAUSALITO SE DECISION MADE: 10-JUN-02 IRVINE, CA 92606 510(k) STATEMENT DEVICE: DCM 2.0 MDS NORDION AB 510(k) NO: K020971(TRADITIONAL) ATTN: E. S MARTELL PHONE NO : 613 592 3400 447 MARCH ROAD SE DECISION MADE: 06-JUN-02 KANATA, ONTARIO, CANADA K2K 1X8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALVED PEELABLE INTRODUCER MEDAMICUS, INC. 510(k) NO: K021004(TRADITIONAL) ATTN: KARYL HASKELL PHONE NO : 763-577-2257 15301 HWY. 55 WEST SE DECISION MADE: 06-JUN-02 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 M MEDEFIL, INC. 510(k) NO: K020996(TRADITIONAL) ATTN: PRADEEP AGGARWAL PHONE NO : 847-895-3000 492 LUNT AVENUE SE DECISION MADE: 24-JUN-02 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 MEDEFIL, INC. 510(k) NO: K020999(TRADITIONAL) ATTN: PRADEEP AGGARWAL PHONE NO : 847-895-3000 492 LUNT AVENUE SE DECISION MADE: 20-JUN-02 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL MEDICAL ADVANCES, INC. 510(k) NO: K021433(TRADITIONAL) ATTN: JERRY FROHLICH PHONE NO : 414-258-3808 10437 INNOVATION DR. SE DECISION MADE: 13-JUN-02 MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JUMP START, MODEL 970300 MEDICAL RESEARCH LABORATORIES, INC510(k) NO: K021168(TRADITIONAL) ATTN: JOEL ORLINSKY PHONE NO : 847-520-0300 1000 ASBURY DR. NO.17 SE DECISION MADE: 26-JUN-02 BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA MEDICOTEST A/S 510(k) NO: K020382(TRADITIONAL) ATTN: EMALEE G MURPHY PHONE NO : 202-778-9424 1800 MASSCHUSETTS AVE., N.W. SE DECISION MADE: 28-JUN-02 SECOND FLOOR 510(k) STATEMENT WASHINGTON,, DC 20036-9000 DEVICE: NEUROLINE, SUBDERMAL NEEDLE ELECTRODES MEDICOTEST A/S 510(k) NO: K020907(TRADITIONAL) ATTN: EMALEE G MURPHY PHONE NO : 202-778-9428 1800 MASSCHUSETTS AVE., N.W. SE DECISION MADE: 14-JUN-02 SUITE 200 510(k) STATEMENT WASHINGTON, DC 20036-1221 DEVICE: DOUBLE SPRINGERS NONOXNOL 9 CONDOM MEDTECH PRODUCTS LTD. 510(k) NO: K012969(ABBREVIATED) ATTN: A. V. K. REDDY PHONE NO : 009 144 6288829 S-59 20TH ST., ANNA NAGAR WEST SE DECISION MADE: 12-JUN-02 CHENNAI, INDIA 600 040 510(k) STATEMENT DEVICE: MEDTRONIC SOFAMOR DANEK ANTERIOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K020844(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 12-JUN-02 MEMPHIS, TN 38132 510(k) STATEMENT DEVICE: EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013962(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 20-JUN-02 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM MICRO THERAPEUTICS, INC. 510(k) NO: K021066(TRADITIONAL) ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 18-JUN-02 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTI MICROLIFE CORP. 510(k) NO: K021305(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 28-JUN-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: AIRCAST, MODEL #3011 MILLENIUM REPROCESSING SERVICES, I510(k) NO: K013297(TRADITIONAL) ATTN: GARY J SFEIR PHONE NO : 716-741-1015 8850 WOODSIDE DRIVE SE DECISION MADE: 14-JUN-02 CLARENCE, NY 14031 510(k) STATEMENT DEVICE: HBS HEADLESS BONE SCREW MILLENNIUM MEDICAL TECHNOLOGIES, I510(k) NO: K020791(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 06-JUN-02 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: H12+HOLTER RECORDER MORTARA INSTRUMENT, INC. 510(k) NO: K021373(SPECIAL) ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600 7865 NORTH 86TH ST. SE DECISION MADE: 27-JUN-02 MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GPF-29 GENERAL PURPOSE COIL SET MRI DEVICES CORP. 510(k) NO: K020850(TRADITIONAL) ATTN: DAVID A MOLYNEAUX PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SE DECISION MADE: 06-JUN-02 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: HNC-127-TRIO NEUROVASCULAR ARRAY COIL MRI DEVICES CORP. 510(k) NO: K021570(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 12-JUN-02 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: OBC-127 BREAST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K021575(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 12-JUN-02 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: UNIDRIVE II PLUS DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K021811(TRADITIONAL) ATTN: JAMES A LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 19-JUN-02 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GARD FILTER, COMBIGARD FILTE / HME MUNKTELL FILTER AB 510(k) NO: K014281(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 26-JUN-02 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACSTOP FILTER,BACSTOP FILTER/HME MUNKTELL FILTER AB 510(k) NO: K014282(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 26-JUN-02 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR NELLCOR PURITAN BENNETT, INC. 510(k) NO: K021089(TRADITIONAL) ATTN: GINA TO PHONE NO : 925-463-4427 4280 HACIENDA DR. SE DECISION MADE: 19-JUN-02 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBDURAL STRIP ELECTRODE NICOLET BIOMEDICAL, INC. 510(k) NO: K021144(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 24-JUN-02 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOPRO EVO INFUSION PUMP NIPRO DIABETES SYSTEMS, INC. 510(k) NO: K013309(TRADITIONAL) ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 24-JUN-02 LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX NIPRO DIABETES SYSTEMS, INC. 510(k) NO: K014114(TRADITIONAL) ATTN: KAELYN B HADLEY PHONE NO : 859-224-0256 1384 COPPERFIELD COURT SE DECISION MADE: 26-JUN-02 LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPLACE SCALLOPED MARGIN IMPLANT SYSTEM NOBEL BIOCARE USA, INC. 510(k) NO: K021584(SPECIAL) ATTN: RICHARD T ROSS PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 05-JUN-02 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT PROFILE CRITICAL CARE XPRESS ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K020297(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 10-JUN-02 WALTHAM, MA 02454-9141 510(k) STATEMENT DEVICE: CARDIOSPECT SC, CARDIOSPECT D90 NUCLEAR CARDIOLOGY SYSTEMS, INC. 510(k) NO: K021823(TRADITIONAL) ATTN: CHARLIE H ROSE PHONE NO : 303-541-0044 5660 AIRPORT BLVD., SUITE 101 SE DECISION MADE: 17-JUN-02 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 NUCLEAR DIAGNOSTICS 510(k) NO: K021656(SPECIAL) ATTN: JAN BERTLING PHONE NO : 460 819 0325 SODER MALARSTRAND 13 SE DECISION MADE: 13-JUN-02 STOCKHOLM, SWEDEN 118 20 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE MESH NUVASIVE, INC. 510(k) NO: K020853(TRADITIONAL) ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918 10065 OLD GROVE RD. SE DECISION MADE: 13-JUN-02 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORS-1000LD O.R. SOLUTIONS, INC. 510(k) NO: K021288(TRADITIONAL) ATTN: STEVE HANNES PHONE NO : 800-343-6771 3901 CENTERVIEW DR. SE DECISION MADE: 27-JUN-02 SUITE W 510(k) STATEMENT CHANTILLY, VA 20151-1689 DEVICE: WARMER 2000LD O.R. SOLUTIONS, INC. 510(k) NO: K021289(TRADITIONAL) ATTN: STEVE HANNES PHONE NO : 800-343-6771 3901 CENTERVIEW DR. SE DECISION MADE: 26-JUN-02 SUITE W 510(k) STATEMENT CHANTILLY, VA 20151-1689 DEVICE: SOFT PLUG ABSORBABLE PLUG-SA OASIS MEDICAL, INC. 510(k) NO: K013613(TRADITIONAL) ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-9857 514 S. VERMONT AVE. SE DECISION MADE: 27-JUN-02 GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT L OCULAR SCIENCES 510(k) NO: K020389(TRADITIONAL) ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 04-JUN-02 SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODE OLYMPIC MEDICAL CORP. 510(k) NO: K020335(TRADITIONAL) ATTN: EDWARD B (TED) WEILER PHONE NO : 206-767-3500 5900 FIRST AVE., SOUTH SE DECISION MADE: 18-JUN-02 SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UHI-3 HIGH FLOW INSUFFLATION UNIT OLYMPUS OPTICAL CO., LTD. 510(k) NO: K014166(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 25-JUN-02 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS OLYMPUS OPTICAL CO., LTD. 510(k) NO: K021886(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 19-JUN-02 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OPTAX SYSTEM OPTAX SYSTEMS, INC. 510(k) NO: K020800(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 10-JUN-02 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSCAR, MODEL OE3000 ORTHOSONICS, LTD. 510(k) NO: K021502(SPECIAL) ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013 2305 GOLD MINE ROAD SE DECISION MADE: 06-JUN-02 BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. J OSYPKA MEDICAL, INC. 510(k) NO: K020896(ABBREVIATED) ATTN: MARKUS J OSYPKA PHONE NO : 858-459-2312 7463 DRAPER AVENUE SE DECISION MADE: 14-JUN-02 LA JOLLA, CA 92037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEXOLONG SETS PAJUNK GMBH 510(k) NO: K013041(TRADITIONAL) ATTN: BURK A BRANDT PHONE NO : 541-752-3953 5010 NW CRESCENT VALLEY DRIVE SE DECISION MADE: 11-JUN-02 CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALOMAR LUXG HANDPIECE PALOMAR 510(k) NO: K020941(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LANE SE DECISION MADE: 19-JUN-02 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBV-VCA IGG ELISA TEST, MODEL EBG-100 PAN BIO PTY. LTD. 510(k) NO: K020706(TRADITIONAL) ATTN: HELEN JENNINGS PHONE NO : 61 7 33571177 116 LUTWYCHE RD. SE DECISION MADE: 13-JUN-02 WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBV-EBNA IGG ELISA KIT, MODEL EBG-100 PAN BIO PTY. LTD. 510(k) NO: K020707(TRADITIONAL) ATTN: HELEN JENNINGS PHONE NO : 61 7 33571177 116 LUTWYCHE RD. SE DECISION MADE: 13-JUN-02 WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBV V VCA IGM ELISA KIT MODEL# EBM-200 PAN BIO PTY. LTD. 510(k) NO: K020717(TRADITIONAL) ATTN: HELEN JERNNINGS PHONE NO : 617 335 71177 116 LUTWYCHE RD. SE DECISION MADE: 13-JUN-02 WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARACON II/FECAL CONCENTRATOR II PARA SCIENTIFIC CO. 510(k) NO: K021420(TRADITIONAL) ATTN: ERIC CARLSON PHONE NO : 503-636-4121 17170 WALL ST. SE DECISION MADE: 04-JUN-02 LAKE OSWEGO, OR 97034 510(k) STATEMENT DEVICE: K-Y BRAND ULTRA GEL PERSONAL LUBRICANT PERSONAL PRODUCTS CO., DIV. OF MCN510(k) NO: K020827(TRADITIONAL) ATTN: MARYLOU PANICO PHONE NO : 908-904-3709 199 GRANDVIEW RD. SE DECISION MADE: 12-JUN-02 SKILLMAN, NJ 08558-9418 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376 DEVICELINK SYSTEM PHILIPS ULTRASOUND 510(k) NO: K021912(SPECIAL) ATTN: DENISE HADLEY PHONE NO : 978-659-3173 3000 MINUTEMAN ROAD SE DECISION MADE: 24-JUN-02 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS PHOENIX DIAGNOSTICS, INC. 510(k) NO: K020364(TRADITIONAL) ATTN: RAN NUNNA PHONE NO : 508-655-8310 8 TECH CIRCLE SE DECISION MADE: 04-JUN-02 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RT-PLUS PE INSERT CLAMP PLUS ORTHOPEDICS 510(k) NO: K021714(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 858-550-3800 6055 LUSK BLVD. SE DECISION MADE: 21-JUN-02 SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REX, VERSION 1.0 POINTDX, INC 510(k) NO: K021099(TRADITIONAL) ATTN: ROBERT ANDERSON PHONE NO : 336-723-1450 635 WEST FOURTH STREET SE DECISION MADE: 27-JUN-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WINSTON-SALEM, NC 27101 DEVICE: SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS R POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K021701(SPECIAL) ATTN: BARBARA J WHITMAN PHONE NO : 215-862-4450 110 UNION SQUARE DR. SE DECISION MADE: 21-JUN-02 NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE PRECISION DYNAMICS CORP. 510(k) NO: K020718(TRADITIONAL) ATTN: KALYNA SNYLYK PHONE NO : 818-897-1111 13880 DEL SUR ST. SE DECISION MADE: 03-JUN-02 SAN FERNANDO, CA 91340-3490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER PRECISION SYSTEMS, INC. 510(k) NO: K013654(TRADITIONAL) ATTN: BILL HADEN PHONE NO : 508-655-7010 16 TECH CIRCLE SE DECISION MADE: 05-JUN-02 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJ PRINCETON BIOMEDITECH CORP. 510(k) NO: K014066(TRADITIONAL) ATTN: JEMO KANG PHONE NO : 732-274-1000 4242 U.S. RT. 1 SE DECISION MADE: 10-JUN-02 MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STAT PRINCETON BIOMEDITECH CORP. 510(k) NO: K014067(TRADITIONAL) ATTN: JEMO KANG PHONE NO : 732-274-1000 4242 U.S. RT. 1 SE DECISION MADE: 10-JUN-02 MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC PRINCETON BIOMEDITECH CORP. 510(k) NO: K014069(TRADITIONAL) ATTN: JEMO KANG PHONE NO : 732-274-1000 4242 U.S. RT. 1 SE DECISION MADE: 10-JUN-02 MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM QUALITY MEDICAL SOLUSIONS LLC 510(k) NO: K021012(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSIDE PARK DR SE DECISION MADE: 25-JUN-02 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CINESCAN S QUANTEL MEDICAL 510(k) NO: K021683(SPECIAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 21-JUN-02 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISET DAT PLUS QUANTIMETRIX CORP. 510(k) NO: K021393(TRADITIONAL) ATTN: GEBHARD NEYER PHONE NO : 310-536-0006 2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 13-JUN-02 REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPATOUCH PHOTOEPILATION SYSTEM RADIANCY (ISRAEL) LTD. 510(k) NO: K020856(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 13-JUN-02 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM RADIANT MEDICAL 510(k) NO: K012512(TRADITIONAL) ATTN: ANDREW CLEELAND PHONE NO : 650-363-8000 250 CHESAPEAKE DRIVE SE DECISION MADE: 11-JUN-02 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIUS SNARE RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K021441(TRADITIONAL) ATTN: MAUREEN FINLAYSON PHONE NO : 978-897-6469 63 GREAT RD. SE DECISION MADE: 14-JUN-02 MAYNARD, MA 01754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RDI HS CRP CALIBRATOR SET REFERENCE DIAGNOSTICS, INC. 510(k) NO: K021607(ABBREVIATED) ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000 19 CROSBY DR. SUITE 30 SE DECISION MADE: 27-JUN-02 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: RDI HS CRP KIT REFERENCE DIAGNOSTICS, INC. 510(k) NO: K021609(TRADITIONAL) ATTN: JOSEPH LAWLOR PHONE NO : 781-276-9000 19 CROSBY DR. SUITE 30 SE DECISION MADE: 27-JUN-02 BEDFORD, MA 01730 510(k) STATEMENT DEVICE: RPI REPLACEMENT HEATING ELEMENTS REPLACEMENT PARTS INDUSTRIES, INC.510(k) NO: K020966(TRADITIONAL) ATTN: IRA LAPIDES PHONE NO : 818-882-8611 P.O. BOX 5019 SE DECISION MADE: 13-JUN-02 CHATSWORTH, CA 91313-5019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR PRO WITH C-FLEX CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K021861(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LANE SE DECISION MADE: 19-JUN-02 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K021448(SPECIAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE ROAD SE DECISION MADE: 03-JUN-02 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ACCU-CHEK ADVANTAGE MODULE ROCHE DIAGNOSTICS CORP. 510(k) NO: K021513(SPECIAL) ATTN: SCOTT THIEL PHONE NO : 800-428-5074 9115 HAGUE ROAD SE DECISION MADE: 11-JUN-02 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ULTRA-LITE 5 TURBO LIGHT CURE UNIT ROLENCE ENT. INC. 510(k) NO: K020874(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 3 4631999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 12-JUN-02 CHUNGLI, CHINA (TAIWAN) 320 510(k) STATEMENT DEVICE: EXCELLITE TURBO LIGHT CURE UNIT ROLENCE ENT. INC. 510(k) NO: K020877(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 3 4631999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 12-JUN-02 CHUNGLI, CHINA (TAIWAN) 320 510(k) STATEMENT DEVICE: EXCELLITE LIGHT CURE UNIT ROLENCE ENT. INC. 510(k) NO: K020884(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 3 4631999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 12-JUN-02 CHUNGLI, CHINA (TAIWAN) 320 510(k) STATEMENT DEVICE: RS2MI MUSCLE STIMULATOR FAMILY RS MEDICAL 510(k) NO: K021763(TRADITIONAL) ATTN: MICHAEL B MCGRAW PHONE NO : 360-896-2503 14401 S.E. FIRST ST. SE DECISION MADE: 13-JUN-02 VANCOUVER, WA 98684 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACUSTIM S.H.P. INTL. PTY., LTD. 510(k) NO: K014273(TRADITIONAL) ATTN: E.D. RICHARDS PHONE NO : 618 837 90700 5/212 GLEN OSMOND RD. SE DECISION MADE: 12-JUN-02 FULLARTON, S.A., AUSTRALIA 5063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES SAFE SHIELD CO. LTD 510(k) NO: K013980(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SE DECISION MADE: 06-JUN-02 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SAFEHEALTH MEDICAL SUPPLY CORP. 510(k) NO: K021667(TRADITIONAL) ATTN: P. M YEH PHONE NO : 886 6 7832197 NO. 1,TOU KANG LI, SE DECISION MADE: 11-JUN-02 HSUEH CHIA COUNTY 510(k) STATEMENT TAINAN HSIEN, CHINA (TAIWAN) DEVICE: SNORE SAT RECORDER, MODEL SS41 SAGATECH ELECTRONICS, INC. 510(k) NO: K002159(TRADITIONAL) ATTN: HEATHER PLATT-MELAX PHONE NO : 403 228 4214 3413 8TH ST., S.E. SE DECISION MADE: 28-JUN-02 CALGARY, ALBERTA, CANADA T2G3A4 510(k) STATEMENT DEVICE: SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM SANARUS MEDICAL, INC. 510(k) NO: K021137(TRADITIONAL) ATTN: VICENT CUTARELLI PHONE NO : 949-595-5424 5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 26-JUN-02 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM SANARUS MEDICAL, INC. 510(k) NO: K021211(SPECIAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-786-1184 5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 26-JUN-02 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT, MODEL S980000 SANDHILL SCIENTIFIC, INC. 510(k) NO: K012232(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD CT SE DECISION MADE: 07-JUN-02 BOULDER, CO 80301 510(k) STATEMENT DEVICE: BELIMED STEAM STERILIZER, MODEL TOP 5000 SAUTER AG 510(k) NO: K021223(TRADITIONAL) ATTN: HANS STADLER PHONE NO : 417 164 48500 ZELGSTRASSE 8 SE DECISION MADE: 26-JUN-02 SULGEN, SWITZERLAND CH-8583 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG10 SCANTIBODIES LABORATORY, INC. 510(k) NO: K021032(TRADITIONAL) ATTN: RICHARD LENART PHONE NO : 619-258-9300 9336 ABRAHAM WAY SE DECISION MADE: 03-JUN-02 SANTEE, CA 92071 510(k) STATEMENT DEVICE: CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATI SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K021388(TRADITIONAL) ATTN: CHUN CHOOI FONG PHONE NO : 60 5 3223200 LOT 72706,JALAN LAHAT,KAWASAN SE DECISION MADE: 10-JUN-02 PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA LAHAT, PERAK, MALAYSIA 31500 DEVICE: SECTRA OSTEOPOROSIS PACKAGE SECTRA-IMTEC AB 510(k) NO: K021527(SPECIAL) ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1100 LAKEVIEW BLVD SE DECISION MADE: 07-JUN-02 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K020943(SPECIAL) ATTN: JOHN LAI PHONE NO : 011 86 2157814213 259 YUSHU RD., SE DECISION MADE: 06-JUN-02 CANGQIAO TOWNSHIP 510(k) STATEMENT SONGJIANG SHANGHAI, CHINA 201600 DEVICE: POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K021506(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-262-8860 12390 EAST END AVENUE SE DECISION MADE: 06-JUN-02 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIVEOUS LIQUID DAM SHOFU DENTAL CORP. 510(k) NO: K021613(TRADITIONAL) ATTN: ROBERT NOBLE PHONE NO : 760-736-3277 1225 STONE DR. SE DECISION MADE: 20-JUN-02 SAN MARCOS, CA 92069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTE SIAM SEMPERMED CORP. LTD. 510(k) NO: K021220(TRADITIONAL) ATTN: JOHN V CALHOUN PHONE NO : 727-787-7250 30798 US HWY 19 NORTH SE DECISION MADE: 06-JUN-02 PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOMAP SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K014113(TRADITIONAL) ATTN: SANDRA ROBINSON PHONE NO : 732-321-3243 186 WOOD AVENUE SOUTH SE DECISION MADE: 14-JUN-02 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO MR 2002B SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K020991(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 732-321-4500 186 WOOD AVENUE SOUTH SE DECISION MADE: 13-JUN-02 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K021021(TRADITIONAL) ATTN: SANDRA ROBINSON PHONE NO : 732-321-3243 186 WOOD AVENUE SOUTH SE DECISION MADE: 06-JUN-02 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RABEA CEMENT RESTRICTOR SIGNUS MEDICAL LLC. 510(k) NO: K020836(TRADITIONAL) ATTN: ANN QUINLAN-SMITH PHONE NO : 763-287-3830 4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 11-JUN-02 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: TOTAL HIP FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC. 510(k) NO: K021673(SPECIAL) ATTN: KIM KELLY PHONE NO : 901-399-6566 1450 E. BROOKS ROAD SE DECISION MADE: 11-JUN-02 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 SOADCO, S.L. 510(k) NO: K010132(TRADITIONAL) ATTN: MERCEDES ROLDAN PHONE NO : 376-800-590 AV FITER I ROSSELL SE DECISION MADE: 04-JUN-02 4 BIS LOCAL 2 510(k) STATEMENT ESCALDES-ENGORDANY, ANDORRA DEVICE: GLO-SPEC I, II AND III SOL WEISS MD INC 510(k) NO: K020959(TRADITIONAL) ATTN: SOL WEISS PHONE NO : 818-346-1515 7012 RESEDA BOULEVARD SE DECISION MADE: 19-JUN-02 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA RESEDA, CA 91335 DEVICE: SOPRO LIGHT SOURCES AND ACCESSORIES SOPRO 510(k) NO: K020915(TRADITIONAL) ATTN: PIERRE MONTILLOT PHONE NO : 330 491 270727 PLACE ST. CHRISTOPHE SE DECISION MADE: 14-JUN-02 LES ACCATES-LA VALENTINE 510(k) STATEMENT MARSEILLE, FRANCE F-13011 DEVICE: OXYARM CO2 SOUTHMEDIC, INC. 510(k) NO: K014211(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 11-JUN-02 MCCORDSVILLE, IN 46051-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 SPACELABS MEDICAL, INC. 510(k) NO: K021097(TRADITIONAL) ATTN: EDWARD M BASILE PHONE NO : 202-626-2903 1730 PENNSYLVANIA AVE. NW SE DECISION MADE: 28-JUN-02 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K021009(TRADITIONAL) ATTN: DAVID M HOOPER PHONE NO : 512-918-2700 12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 18-JUN-02 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSE ST. SHINE OPTICAL CO., LTD. 510(k) NO: K021295(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 04-JUN-02 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: QUPID PLUS E.R. STANBIO LABORATORY 510(k) NO: K020378(TRADITIONAL) ATTN: KIRK JOHNSON PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 21-JUN-02 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARTOX DRUG OF ABUSE SCREENING TEST STARPLEX SCIENTIFIC, INC. 510(k) NO: K021006(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT STREET SE DECISION MADE: 10-JUN-02 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERA IMPLANT STERNGOLD 510(k) NO: K021045(ABBREVIATED) ATTN: MARIA RAO PHONE NO : 508-226-5660 23 FRANK MOSSBERG DR. SE DECISION MADE: 26-JUN-02 ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRITERTION, MODEL #1067511 STERNGOLD 510(k) NO: K021741(ABBREVIATED) ATTN: MARIA RAO PHONE NO : 508-226-5660 23 FRANK MOSSBERG DR. SE DECISION MADE: 26-JUN-02 ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PARA 5X STRECK LABORATORIES, INC. 510(k) NO: K021922(SPECIAL) ATTN: PAUL KITTELSON PHONE NO : 402-537-5312 7002 SOUTH 109TH ST. SE DECISION MADE: 25-JUN-02 LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS SULZER CARBOMEDICS, INC. 510(k) NO: K013022(TRADITIONAL) ATTN: LISA PETERSON PHONE NO : 512-435-3523 1300 EAST ANDERSON LN. SE DECISION MADE: 13-JUN-02 AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STEN SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K021729(SPECIAL) ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018 651 CAMPUS DR. SE DECISION MADE: 21-JUN-02 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 1133 IVD PC VERSION SUN NUCLEAR CORP. 510(k) NO: K021463(SPECIAL) ATTN: JIM MIXON PHONE NO : 321-259-6862 425-A PINEDA COURT SE DECISION MADE: 06-JUN-02 MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVILBISS PULMO-AIDE COMPACT COMPRESSOR SUNRISE MEDICAL 510(k) NO: K020932(TRADITIONAL) ATTN: RAY HOFFMAN PHONE NO : 814-443-7442 100 DEVILBISS DR. SE DECISION MADE: 28-JUN-02 SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DEVILBISS PD1000 SUNRISE MEDICAL HHG, INC. 510(k) NO: K020329(TRADITIONAL) ATTN: BRIAN HERSHEY PHONE NO : 814-443-7577 100 DEVILBISS DR. SE DECISION MADE: 19-JUN-02 SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM SUNRISE MEDICAL HHG, INC. 510(k) NO: K020900(TRADITIONAL) ATTN: JOE MITCHELL PHONE NO : 814-443-7481 100 DEVILBISS DR. SE DECISION MADE: 03-JUN-02 SOMERSET, PA 15501 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: REPROCESSED ARTHROSCOPIC SHAPERS SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K012667(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E COLUMBINE DRIVE SE DECISION MADE: 03-JUN-02 PHOENIX, AZ 85032-5655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROSURGICAL ELECTRODES SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K012669(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E COLUMBINE DRIVE SE DECISION MADE: 27-JUN-02 PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L.E.DEMETRON SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K021797(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 27-JUN-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEMENTS DIAGNOSTIC UNIT SYBRON ENDO/ANALYTIC 510(k) NO: K021298(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 19-JUN-02 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 3.5 MM BROAD LC-DCP PLATES SYNTHES (USA) 510(k) NO: K020872(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 12-JUN-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS SYNTHES (USA) 510(k) NO: K021850(SPECIAL) ATTN: MATTHEW M HULL PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 10-JUN-02 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I SYSMEX CORPORATION OF AMERICA 510(k) NO: K021241(TRADITIONAL) ATTN: NINA M GAMPERLING' PHONE NO : 847-726-3675 6699 WILDLIFE WAY SE DECISION MADE: 25-JUN-02 LONG GROVE, IL 60047-9596 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANIT TANITA CORP. OF AMERICA 510(k) NO: K014009(TRADITIONAL) ATTN: CAROL ALLOIAN (BENSON) PHONE NO : 847-640-9251 2625 SOUTH CLEARBROOK DRIVE SE DECISION MADE: 24-JUN-02 ARLINGTON HGTS., IL 60005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILICONE TRACHEAL T-TUBES TECHNICAL PRODUCTS, INC. 510(k) NO: K013321(TRADITIONAL) ATTN: NORBERT D THOMPSON PHONE NO : 404-981-8434 2416 PARK CENTRAL BLVD. SE DECISION MADE: 04-JUN-02 DECATUR, GA 30035 510(k) STATEMENT DEVICE: TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB TELESIS TECHNOLOGIES INC. 510(k) NO: K020783(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 226 9801088 14F-3 & -4, NO.81, SEC 1, SE DECISION MADE: 07-JUN-02 HSIN-TAI-WU RD. 510(k) STATEMENT HIS-CHIH CITY, TAIPEI HSIEN, CHINA (TAIWAN) 221 DEVICE: TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K020967(TRADITIONAL) ATTN: STEVE ARICK PHONE NO : 734-663-4145 1311 VALENCIA AVE. SE DECISION MADE: 20-JUN-02 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO GAS FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K021020(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 10-JUN-02 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER TFX MEDICAL, INC. 510(k) NO: K020985(TRADITIONAL) ATTN: RICK LYKINS PHONE NO : 603-532-7706 50 PLANTATION DRIVE SE DECISION MADE: 25-JUN-02 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER TFX MEDICAL, INC. 510(k) NO: K021034(TRADITIONAL) ATTN: RICK LYKINS PHONE NO : 603-532-0204 50 PLANTATION DRIVE SE DECISION MADE: 26-JUN-02 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 91 THE BINDING SITE, LTD. 510(k) NO: K021081(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 17-JUN-02 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM THERASENSE, INC. 510(k) NO: K020866(SPECIAL) ATTN: DONNA K TEMPLEMAN PHONE NO : 510-239-2670 1360 SOUTH LOOP ROAD SE DECISION MADE: 11-JUN-02 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIPOWER POWERDRIVE AND RIMPOWER X & SX TISPORT 510(k) NO: K020539(TRADITIONAL) ATTN: SANDRA GLADSTONE PHONE NO : 509-586-6117 1426 EAST THIRD AVE. SE DECISION MADE: 20-JUN-02 KENNEWICK, WA 99337-9669 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER TISPORT 510(k) NO: K020639(TRADITIONAL) ATTN: SANDRA GLADSTONE PHONE NO : 509-586-6117 1426 EAST THIRD AVE. SE DECISION MADE: 20-JUN-02 KENNEWICK, WA 99337-9669 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAATEK COTTONOID PATTIES TRAATEK, INC. 510(k) NO: K020736(TRADITIONAL) ATTN: TERRY JOHNSTON PHONE NO : 650-740-0345 917 DURISTON ROAD SE DECISION MADE: 03-JUN-02 REDWOOD CITY, CA 94062 510(k) STATEMENT DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K021627(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036 29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 20-JUN-02 WESTLAKE, OH 44145 510(k) STATEMENT DEVICE: U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 U-SYSTEMS, INC. 510(k) NO: K013902(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 05-JUN-02 LOS ALTOS,, CA 94204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION 510(k) NO: K020630(TRADITIONAL) ATTN: KEN SETO PHONE NO : 604 875 4985 535-2660 OAK STREET SE DECISION MADE: 13-JUN-02 VANCOUVER, BC, CANADA V6H 3Z1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATH URESIL, L.P. 510(k) NO: K021632(SPECIAL) ATTN: CHARLES P GILL PHONE NO : 847-982-1154 5418 WEST TOUHY AVE. SE DECISION MADE: 13-JUN-02 SKOKIE, IL 60077 510(k) STATEMENT DEVICE: MILLENNIUM 5000 MEUROVASCULAR COIL USA INSTRUMENTS, INC. 510(k) NO: K021141(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 27-JUN-02 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACURECT VACUUM CONSTRICTION DEVICE VACURECT MANUFACTURING (PTY) LTD. 510(k) NO: K020969(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 05-JUN-02 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY VASOMEDICAL, INC. 510(k) NO: K020857(TRADITIONAL) ATTN: THOMAS R VARRICCHIONE PHONE NO : 516-997-4600 180 LINDEN AVE. SE DECISION MADE: 14-JUN-02 WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARMA 800 SERIES MANUAL WHEELCHAIR VESTIL MANUFACTURING CORP. 510(k) NO: K021866(TRADITIONAL) ATTN: RICK MICHAEL PHONE NO : 260-668-5677 900 GROWTH PARKWAY SE DECISION MADE: 14-JUN-02 ANGOLA, IN 46703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORACAM VIDEO DENTAL CONCEPTS, INC. 510(k) NO: K020957(TRADITIONAL) ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450 110 EAST GRANADA BOULEVARD SE DECISION MADE: 13-JUN-02 SUITE 208; P.O. BOX 36 510(k) STATEMENT ORMOND BEACH, FL 32175-0036 DEVICE: VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYST VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K021290(ABBREVIATED) ATTN: GRAHAM BAILLIE PHONE NO : 508-366-3668 134 FLANDERS RD. SE DECISION MADE: 28-JUN-02 WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVAWAVE MICROWAVE SYSTEM VIVANT MEDICAL, INC. 510(k) NO: K011676(TRADITIONAL) ATTN: STEVEN KIM PHONE NO : 650-694-2900 1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 18-JUN-02 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLACH LOOP ELECTRODE WALLACH SURGICAL DEVICES, INC. 510(k) NO: K020711(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-799-2000 235 EDISON RD. SE DECISION MADE: 03-JUN-02 ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELCH ALLYN ABPM 6100 WELCH ALLYN, INC. 510(k) NO: K021756(SPECIAL) ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4100 4341 STATE STREET RD. SE DECISION MADE: 27-JUN-02 SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOPAL 50 WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K021733(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 497 231 3705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 26-JUN-02 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC LIGHT SOURCE XL202/L3 WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K020889(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617-868-3995 91 TROWBRIDGE STREET SE DECISION MADE: 05-JUN-02 CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) WORLDWIDE MEDICAL CORP. 510(k) NO: K020869(TRADITIONAL) ATTN: FRANCISCO J ROJAS PHONE NO : 949-598-1975 13 SPECTRUM POINTE DRIVE SE DECISION MADE: 11-JUN-02 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K021536(TRADITIONAL) ATTN: V. NADARAJAN PHONE NO : 603 870 69788 BARU SALAK SE DECISION MADE: 10-JUN-02 TINGGI 43900 SEPANG 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DARUL EHSAN, MALAYSIA DEVICE: DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STE WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K021561(TRADITIONAL) ATTN: V. NADARAJAN PHONE NO : 603 846 9788 BARU SALAK SE DECISION MADE: 11-JUN-02 TINGGI 43900 SEPANG 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DARUL EHSAN, MALAYSIA DEVICE: SOFTLASE G2-SURGICAL DIODE LASER SYSTEM ZAP LASERS, LLC 510(k) NO: K021227(TRADITIONAL) ATTN: JAY GOBLE PHONE NO : 888-876-4546 2643 PLEASANT HILL ROAD SE DECISION MADE: 26-JUN-02 PLEASANT HILL, CA 94523 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 294 TOTAL WITH SUMMARIES 239 TOTAL WITH STATEMENTS 55
Updated 4/28/2004
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