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Medical Devices
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June 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-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 BY
GENX 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
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