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510(k)s Final Decisions Rendered for March 2002 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAR-2002 THROUGH 31-MAR-2002
DEVICE: 3M ATTEST 290 AUTO-READER
3M CO. 510(k) NO: K004009(TRADITIONAL)
ATTN: STEPHAN NORSTED PHONE NO : 952-946-8080
5353 WAYZATA BLVD. SE DECISION MADE: 25-MAR-02
SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416
DEVICE: UNICEM
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K020256(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 25-MAR-02
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARBITURATES
ABBOTT LABORATORIES 510(k) NO: K012996(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD MS 1-8 SE DECISION MADE: 20-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPHETAMINE/METHAMPHETAMINE
ABBOTT LABORATORIES 510(k) NO: K012998(TRADITIONAL)
ATTN: ALICIA SIMPSON PHONE NO : 972-518-7864
1920 HURD DR 8-21 SE DECISION MADE: 13-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METHADONE
ABBOTT LABORATORIES 510(k) NO: K013001(TRADITIONAL)
ATTN: ALICIA SIMPSON PHONE NO : 972-518-7864
1920 HURD DRIVE SE DECISION MADE: 20-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCAINE
ABBOTT LABORATORIES 510(k) NO: K013004(TRADITIONAL)
ATTN: ALICIA SIMPSON PHONE NO : 972-518-7864
1920 HURD DR 8-21 SE DECISION MADE: 13-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHENCYCLIDINE
ABBOTT LABORATORIES 510(k) NO: K013096(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD DRIVE SE DECISION MADE: 13-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPOXYPHENE
ABBOTT LABORATORIES 510(k) NO: K013100(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD DRIVE SE DECISION MADE: 20-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENZODIAZEPINES
ABBOTT LABORATORIES 510(k) NO: K013143(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD SE DECISION MADE: 13-MAR-02
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNABINOIDS
ABBOTT LABORATORIES 510(k) NO: K013247(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD SE DECISION MADE: 13-MAR-02
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPIATES
ABBOTT LABORATORIES 510(k) NO: K013314(TRADITIONAL)
ATTN: ALICIA SIMPSON PHONE NO : 972-518-7864
1920 HURD DRIVE SE DECISION MADE: 13-MAR-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
ACIST MEDICAL SYSTEMS, INC. 510(k) NO: K012983(TRADITIONAL)
ATTN: CARL M BEAURLINE PHONE NO : 612-995-9319
7450 FLYING CLOUDS DR. SE DECISION MADE: 13-MAR-02
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: REPROCESSED DISPOSABLE TROCARS
ADVEN MEDICAL 510(k) NO: K013987(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 01-MAR-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP -MIETHKE SHUNT SYSTEM
AESCULAP, INC. 510(k) NO: K011030(TRADITIONAL)
ATTN: JOYCE THOMAS PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 01-MAR-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAEDISCOPE, MODEL # P010A AND PF011A
AESCULAP, INC. 510(k) NO: K014149(TRADITIONAL)
ATTN: GEORG KELLER PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 18-MAR-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELSON ELECTROSURGICAL UNIT, MODEL GN640
AESCULAP, INC. 510(k) NO: K014172(TRADITIONAL)
ATTN: LISA MILLINGTON PHONE NO : 610-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 19-MAR-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
AESCULAP, INC. 510(k) NO: K014207(TRADITIONAL)
ATTN: LISA MILLINGTON PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 21-MAR-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTYLE OXYGEN CONCENTRATOR
AIRSEP CORP. 510(k) NO: K020324(TRADITIONAL)
ATTN: CHARLOTTE H HAMILTON PHONE NO : 716-691-0202
290 CREEKSIDE DR. SE DECISION MADE: 13-MAR-02
BUFFALO, NY 14228-2070 510(k) STATEMENT
DEVICE: PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATM
AKSYS, LTD. 510(k) NO: K010131(TRADITIONAL)
ATTN: JAN L ZORN PHONE NO : 847-229-2020
TWO MARRIOTT DRIVE SE DECISION MADE: 26-MAR-02
LINCOLNSHIRE, IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K014081(TRADITIONAL)
ATTN: JOAN KACHAROPOULOS PHONE NO : 845-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 05-MAR-02
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERTORS SMS POLYOLEFIN GOWN
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K020593(SPECIAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. MPWM-1E SE DECISION MADE: 18-MAR-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAZELLE WHEELCHAIR
ALUM CREEK WHEELCHAIR CO., INC. 510(k) NO: K020536(TRADITIONAL)
ATTN: RICHARD ROY PHONE NO : 614-221-1010
393 EAST TOWN STREET SE DECISION MADE: 15-MAR-02
COLUMBUS, OH 43215 510(k) STATEMENT
DEVICE: RAPIDONE-OXY TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K014101(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734
9110 RED BRANCH ROAD SE DECISION MADE: 20-MAR-02
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMUBIND PLASMA PAI-1 ELISA,MODEL 822
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K013168(TRADITIONAL)
ATTN: JOHN B BERRYMAN PHONE NO : 203-661-0000
222 RAILROAD AVE. SE DECISION MADE: 07-MAR-02
GREENWICH, CT 06830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K013318(TRADITIONAL)
ATTN: JOHN BERRYMAN PHONE NO : 203-661-0000
222 RAILROAD AVE. SE DECISION MADE: 08-MAR-02
GREENWICH, CT 06830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMUBIND TPA ELISA, MODEL 860
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K013492(TRADITIONAL)
ATTN: JOHN B BERRYMAN PHONE NO : 203-661-0000
222 RAILROAD AVE. SE DECISION MADE: 13-MAR-02
GREENWICH, CT 06830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K020446(SPECIAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6309
10700 BREN RD., WEST SE DECISION MADE: 13-MAR-02
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SPARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K020663(SPECIAL)
ATTN: MARK MCINTYRE PHONE NO : 952-930-6120
10700 BREN RD., WEST SE DECISION MADE: 28-MAR-02
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/A
AMLUCK, INC. 510(k) NO: K012796(TRADITIONAL)
ATTN: YANG TIEN-HSING PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-02
NSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGELTOUCH VENTED IV ADMINISTRATION SET
ANGIPLAST PRIVATE LTD. 510(k) NO: K012189(TRADITIONAL)
ATTN: ASHIT B SHAH PHONE NO : 917 958 50661
4803, PHASE IV, G.I.D.C., SE DECISION MADE: 05-MAR-02
VATVA 510(k) SUMMARY AVAILABLE FROM FDA
AHMEDABAD, INDIA 382 445
DEVICE: ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
AR ALLIANCE HEALTHCARE SDN. BHD. 510(k) NO: K020359(TRADITIONAL)
ATTN: CHUA CHOON CHUAN PHONE NO : 60 04 5937616
8, LORONG INDUSTRI 11, KAWASAN SE DECISION MADE: 06-MAR-02
PERINDUSTRIAN BUKIT PANCHOR, 510(k) STATEMENT
NIBONG TEBAL, PULAU PINANG, MALAYSIA 14300
DEVICE: TROJAN PASSION BERRY GEL
ARMKEL LLC 510(k) NO: K013433(TRADITIONAL)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-655-6308
P.O. BOX 1001 HALF ACRE RD SE DECISION MADE: 05-MAR-02
CRANBURY,, NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPENING/CLOSING WEDGE OSTETOMY PLATES
ARTHREX, INC. 510(k) NO: K014155(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 18-MAR-02
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTEC PLASMA WANDS
ARTHROCARE CORP. 510(k) NO: K014290(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
680 VAQUEROS AVENUE SE DECISION MADE: 28-MAR-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER COR
ARTHROCARE CORP. 510(k) NO: K020557(SPECIAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 21-MAR-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER COR
ARTHROCARE CORP. 510(k) NO: K020621(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 28-MAR-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE;
ARTHROCARE CORP. 510(k) NO: K020622(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 28-MAR-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORBABLE LACTOSORB-L ACL CROSSPIN
ARTHROTEK, INC. 510(k) NO: K014305(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 29-MAR-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMASTAR ER:YAG LASER SYSTEM
ASCLEPION-MEDITEC AG 510(k) NO: K014057(TRADITIONAL)
ATTN: WILLIAM KELLEY PHONE NO :
23832 VIA MONTE SE DECISION MADE: 08-MAR-02
COTO DE CAZA, CA 92708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE
ASEPTICO, INC. 510(k) NO: K020137(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157
8333 216TH ST., S.E. SE DECISION MADE: 04-MAR-02
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K020156(TRADITIONAL)
ATTN: EILEEN MCCAFFERTY PHONE NO : 00 44 1382422000
THE TECHNOLOGY PARK SE DECISION MADE: 06-MAR-02
LUNA PLACE 510(k) STATEMENT
DUNDEE, SCOTLAND, UNITED KINGDOM DD2 1XA
DEVICE: ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
BAXTER HEALTHCARE CORP. 510(k) NO: K020485(SPECIAL)
ATTN: MARY KONKOWSKI PHONE NO : 847-270-5619
RT. 120 & WILSON RD. SE DECISION MADE: 12-MAR-02
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
BAYER CORP. 510(k) NO: K020806(SPECIAL)
ATTN: THOMAS F FLYNN PHONE NO : 508-359-3877
63 NORTH ST. SE DECISION MADE: 27-MAR-02
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
BAYER DIAGNOSTICS CORP. 510(k) NO: K020217(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 15-MAR-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
BAYLIS MEDICAL CO., INC. 510(k) NO: K014075(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DR. #33 SE DECISION MADE: 07-MAR-02
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) STATEMENT
DEVICE: BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
BD 510(k) NO: K020523(TRADITIONAL)
ATTN: PASQUALE AMOTO PHONE NO : 201-847-4513
ONE BECTON DRIVE MC226 SE DECISION MADE: 20-MAR-02
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VIGIL LIPID CONTROL
BECKMAN COULTER, INC. 510(k) NO: K020521(SPECIAL)
ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8503
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 01-MAR-02
P.O. BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K020322(TRADITIONAL)
ATTN: BRADFORD M SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 27-MAR-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOREAL 3D SYSTEM
BIO MEDI COM 510(k) NO: K020068(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 04-MAR-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
BIOGENEX LABORATORIES 510(k) NO: K012960(TRADITIONAL)
ATTN: GURVINDER S NANDA PHONE NO : 925-543-1336
4600 NORRIS CANYON RD. SE DECISION MADE: 08-MAR-02
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE MAESTRO SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K020645(SPECIAL)
ATTN: DONALD E DALTON PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 15-MAR-02
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXAC
BIOMERIEUX, INC. 510(k) NO: K020871(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8500
595 ANGLUM DR. SE DECISION MADE: 29-MAR-02
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
BIOMET, INC. 510(k) NO: K020580(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 22-MAR-02
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTITOME 20-10 MICROKERATOME
BIOVISION AG 510(k) NO: K014000(TRADITIONAL)
ATTN: DAVID S FERNQUIST PHONE NO : 949-496-0897
27 MAUCHLY, UNIT 206 SE DECISION MADE: 11-MAR-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAYAK HYDROPHILIC GUIDE WIRES
BOSTON SCIENTIFIC CORP. 510(k) NO: K014195(TRADITIONAL)
ATTN: MARK MURPHY PHONE NO : 763-494-2377
ONE SCIMED PLACE SE DECISION MADE: 19-MAR-02
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN-TIME RETRIEVAL DEVICE
BOSTON SCIENTIFIC, TARGET 510(k) NO: K014109(TRADITIONAL)
ATTN: SETH A SCHULMAN PHONE NO : 510-440-7753
47900 BAYSIDE PARKWAY SE DECISION MADE: 12-MAR-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3 (MIRCO-MULTILEAF COLLIMATOR
BRAINLAB AG 510(k) NO: K004022(TRADITIONAL)
ATTN: STEFAN VILSMEIER PHONE NO : 498 999 16680
AMMERTHALSTRASSE 8 SE DECISION MADE: 26-MAR-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION TRAUMA
BRAINLAB AG 510(k) NO: K012448(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 99166800
AMMERTHALSTRASSE 8 SE DECISION MADE: 14-MAR-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX EXAMINATION GLOVES (POWDER FREE)
BRIGHTWAY GLOVES PVT. LTD. 510(k) NO: K014279(TRADITIONAL)
ATTN: N. PARAMASIVAN PHONE NO : 91 465 2276291
PIONEER MANIKANDAN BUILDINGS SE DECISION MADE: 20-MAR-02
VADASERY, NAGAR COIL 510(k) SUMMARY AVAILABLE FROM FDA
TAMIL NADU, INDIA 629001
DEVICE: LATEX EXAMINATION GLOVE (POWDERED)
BRIGHTWAY GLOVES PVT. LTD. 510(k) NO: K014280(TRADITIONAL)
ATTN: N. PARAMASIVAN PHONE NO : 91 465 2276291
PIONEER MANIKANDAN BUILDINGS SE DECISION MADE: 20-MAR-02
VADASERY, NAGAR COIL 510(k) SUMMARY AVAILABLE FROM FDA
TAMIL NADU, INDIA 629001
DEVICE: MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE
BYPASS LTD. 510(k) NO: K020470(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 08-MAR-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O'REGAN DISPOSABLE ANOSCOPE
CANADIAN THEATRE PRODUCTS LTD. 510(k) NO: K020702(TRADITIONAL)
ATTN: ANN-MARIE O'KEEFE PHONE NO : 604 904 9577
#210-828 HARBOUSIDE DRIVE SE DECISION MADE: 29-MAR-02
NORTH VANCOUVER, B.C., CANADA V7P 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
CARDIAC ASSIST DEVICES, INC. 510(k) NO: K012520(TRADITIONAL)
ATTN: RASSOLL RASHIDI PHONE NO : 216-791-2234
11000 CEDAR AVE., SUITE 451 SE DECISION MADE: 27-MAR-02
CLEVELAND, OH 44106-3052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
CARDIOFOCUS, INC. 510(k) NO: K013201(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH STREET SE DECISION MADE: 18-MAR-02
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLASSIC TENS
CARE REHAB, INC. 510(k) NO: K020437(TRADITIONAL)
ATTN: CHRISTIAN HUNT PHONE NO : 703-448-9644
1124 DOMINION COURT SE DECISION MADE: 15-MAR-02
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHASE CARDIOVASCULAR PATCH KIT
CHASE MEDICAL, INC. 510(k) NO: K020233(TRADITIONAL)
ATTN: DAVE HERNON PHONE NO : 972-783-0644
1710 FIRMAN DRIVE SE DECISION MADE: 14-MAR-02
SUITE 100 510(k) STATEMENT
RICHARDSON, TX 75081
DEVICE: QACA IGG/IGM ELISA KIT
CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K020241(TRADITIONAL)
ATTN: NEIL B STRINGER PHONE NO : 44 151 3488023
MANAGEMENT CENTRE, INWARD WAY SE DECISION MADE: 13-MAR-02
ELLESMERE PORT 510(k) STATEMENT
CHESHIRE, UNITED KINGDOM CH65 3EN
DEVICE: UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K013949(TRADITIONAL)
ATTN: KETIH PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 27-MAR-02
DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K020544(SPECIAL)
ATTN: KEITH PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 12-MAR-02
DOVER, NH 03820 510(k) STATEMENT
DEVICE: CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSOR
CLINICON CORP. 510(k) NO: K014236(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 26-MAR-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: COAPT SYSTMES ENDOTINE DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K014153(TRADITIONAL)
ATTN: JUDE PAGANELLI PHONE NO : 650-289-1010
261 HAMILTON AVENUE SE DECISION MADE: 15-MAR-02
SUITE 413 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94301
DEVICE: CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
CODAN US CORP. 510(k) NO: K013714(TRADITIONAL)
ATTN: MARILYN R POURAZAR PHONE NO : 800-332-6326
3511 WEST SUNFLOWER AVE. SE DECISION MADE: 28-MAR-02
SANTA ANA, CA 92704-6944 510(k) STATEMENT
DEVICE: CODMAN HAKIM SHUNT SYSTEMS
CODMAN & SHURTLEFF, INC. 510(k) NO: K020667(SPECIAL)
ATTN: ELIZABETH DOLAN PHONE NO : 508-828-3262
325 PARAMOUNT DR. SE DECISION MADE: 28-MAR-02
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT WHEELCHAIRS
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K020451(TRADITIONAL)
ATTN: ERIC LEE PHONE NO : 886 5 2890303
NO. 120 NAN SHIANG TSUEN, SE DECISION MADE: 14-MAR-02
SHOEI SHANG SHIANG 510(k) STATEMENT
HSIANG, CHIA-YI, CHINA (TAIWAN)
DEVICE: ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
COMPUTER MOTION, INC. 510(k) NO: K013551(TRADITIONAL)
ATTN: DAVID U THOMAS PHONE NO : 805-968-9600
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 28-MAR-02
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PBS, PBSW WITH CATIONS AND PHENOL RED
CONCEPTION TECHNOLOGIES 510(k) NO: K020490(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 28-MAR-02
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
CONSOLIDATED TECHNOLOGY 510(k) NO: K020237(TRADITIONAL)
ATTN: CANDICE BETZ PHONE NO : 512-445-5100
4401 FREIDRICH LANE BLDG 1 SE DECISION MADE: 19-MAR-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78744-1832
DEVICE: "COOLTOUCH" AND "COOLTOUCH-II" ND:YAG LASER SYSTEMS
COOLTOUCH CORP. 510(k) NO: K014035(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912
9085 FOOTHILLS BOULEVARD SE DECISION MADE: 07-MAR-02
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGI
CORDIS CORP. 510(k) NO: K020316(TRADITIONAL)
ATTN: KAREN WILK PHONE NO : 908-412-7446
7 POWDERHORN DRIVE SE DECISION MADE: 20-MAR-02
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE
CORDIS NEUROVASCULAR, INC. 510(k) NO: K020680(SPECIAL)
ATTN: MARITZA CELAYA PHONE NO : 786-313-6546
14000 N.W. 57TH CT. SE DECISION MADE: 27-MAR-02
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
CORIN U.S.A. 510(k) NO: K012377(TRADITIONAL)
ATTN: JOEL BATTS PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 11-MAR-02
SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: COSMED QUARK C12/QUARK T12
COSMED S.R.L. 510(k) NO: K014262(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 26-MAR-02
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: CERASORB ORTHO
CURASAN AG 510(k) NO: K014156(TRADITIONAL)
ATTN: THOMAS ARROWSMITH-LOWE PHONE NO : 505-336-7821
5 EAGLE CREEK ROAD SE DECISION MADE: 18-MAR-02
P.O. BOX 3148 510(k) SUMMARY AVAILABLE FROM FDA
RUIDOSO, NM 88355
DEVICE: SECCA SYSTEM
CURON MEDICAL, INC. 510(k) NO: K014216(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 21-MAR-02
WASHTINGTON,, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K020142(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 14-MAR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
DADE BEHRING, INC. 510(k) NO: K020160(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 14-MAR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
DADE BEHRING, INC. 510(k) NO: K020162(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 14-MAR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH TRIME
DADE BEHRING, INC. 510(k) NO: K020248(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BOULEVARD SE DECISION MADE: 14-MAR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
DADE BEHRING, INC. 510(k) NO: K020441(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
GLASGOW SITE SE DECISION MADE: 28-MAR-02
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DRIED GRAM NEGATIVE MIC/COMBO PANELS
DADE MICROSCAN, INC. 510(k) NO: K020037(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 22-MAR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RADID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH PIPER
DADE MICROSCAN, INC. 510(k) NO: K020511(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BLVD. SE DECISION MADE: 06-MAR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AN
DATEX-OHMEDA 510(k) NO: K020479(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 26-MAR-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAVLITE MICROENDOSCOPE & ACCESSORIES
DAVLITE TECHNOLOGIES 510(k) NO: K020310(TRADITIONAL)
ATTN: DAVID A MCNALLY PHONE NO : 508-829-4602
37 KRIS ALLEN DRIVE SE DECISION MADE: 20-MAR-02
HOLDEN, MA 01520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRSA-SCREEN
DENKA SEIKEN'S 510(k) NO: K011400(TRADITIONAL)
ATTN: KEVIN MANGAN PHONE NO : 813 366 00421
3-4-2 NIHONBASHI SE DECISION MADE: 27-MAR-02
KAYABACHO, CHUO-KU 510(k) SUMMARY AVAILABLE FROM FDA
TOKYO, JAPAN 103
DEVICE: LP(A)-LATEX SEIKEN ASSAY KIT
DENKA SEIKEN'S 510(k) NO: K013359(TRADITIONAL)
ATTN: YOUSUKE MEGURO PHONE NO : 03 366 99421
3-4-2 NIHONBASHI SE DECISION MADE: 08-MAR-02
KAYABACHO, CHUO-KU 510(k) SUMMARY AVAILABLE FROM FDA
TOKYO, JAPAN 103-0025
DEVICE: NEW PROPHY POWDER
DENTSPLY INTL. 510(k) NO: K014188(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 15-MAR-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUIT TCP GRANULES
DEPUY ACROMED 510(k) NO: K014053(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 08-MAR-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
DEPUY ACROMED 510(k) NO: K020522(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 21-MAR-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K013984(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 28-MAR-02
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K020128(TRADITIONAL)
ATTN: CARROLL POTTS PHONE NO : 281-332-9678
445 MEDICAL CENTER BLVD. SE DECISION MADE: 01-MAR-02
WEBSTER, TX 77598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K020596(TRADITIONAL)
ATTN: LINDA STUNDTNER PHONE NO : 508-429-0450
331 FISKE STREET SE DECISION MADE: 23-MAR-02
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1,25-DIHYDROXYVITAMIN D125I RIA
DIASORIN, INC. 510(k) NO: K014030(TRADITIONAL)
ATTN: DAVID IKEDA PHONE NO : 651-351-5592
1951 NORTHWESTERN AVE. SE DECISION MADE: 26-MAR-02
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082-0285
DEVICE: FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K014072(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 08-MAR-02
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRG DISPOSABLE VAGINAL SPECULUM
DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K012535(TRADITIONAL)
ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422
143 WOLCOTT RD. SE DECISION MADE: 01-MAR-02
WOLCOTT, CT 06716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
DOLPHIN MEDICAL INC. 510(k) NO: K012989(TRADITIONAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389
9433 S. MORNING GLORY LANE SE DECISION MADE: 20-MAR-02
HIGHLANDS RANCH, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
DON WILSON/WILSON-COOK MEDICAL, IN510(k) NO: K020526(SPECIAL)
ATTN: MARGARET J POSNER PHONE NO : 800-245-4717
4900 BETHANAIA STATION RD. SE DECISION MADE: 19-MAR-02
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOWEL DRAPE, MODELS 4409, 4410
DYNAREX CORP. 510(k) NO: K012957(TRADITIONAL)
ATTN: JOHN GAGLIARDI PHONE NO : 513-573-0085
7736 WOODSIDE COURT SE DECISION MADE: 06-MAR-02
MAINEVILLE, OH 45039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVI
EASTMAN KODAK COMPANY 510(k) NO: K020635(SPECIAL)
ATTN: SUSAN PATE PHONE NO : 585-781-6314
343 STATE ST. SE DECISION MADE: 21-MAR-02
ROCHESTER, NY 14650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K014276(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 01-MAR-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
EBI, L.P. 510(k) NO: K020403(SPECIAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 08-MAR-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K014052(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 08-MAR-02
IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON M
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K014054(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 08-MAR-02
IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS SPINAL FIXATION SYSTEM
ENDIUS, INC. 510(k) NO: K014090(TRADITIONAL)
ATTN: GENE DIPOTO PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 11-MAR-02
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBODISSECTING ENDOSCOPE
ENDO SURGICAL DEVICES, INC. 510(k) NO: K013680(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 04-MAR-02
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS HEPA FILTER AND HME COMBINATIONS
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K013089(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 14-MAR-02
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS PULMONARY FUNCTION TESTING FILTER
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K013123(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 14-MAR-02
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERPRO 16
ERADLINK, INC. 510(k) NO: K020243(TRADITIONAL)
ATTN: ALBERT J KOUBA PHONE NO : 530-432-3791
19529 CHAPARRAL CIR. SE DECISION MADE: 05-MAR-02
PENN VALLEY, CA 95946-9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH DILATING TIP TROCAR, MODEL #512XD
ETHICON ENDO-SURGERY, INC. 510(k) NO: K020428(SPECIAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 04-MAR-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPL-50 SPIROLYSER
FIM MEDICAL 510(k) NO: K010761(TRADITIONAL)
ATTN: ERIC DEREI PHONE NO : 33 4 72348989
30 RUE CAMILLE SE DECISION MADE: 05-MAR-02
LYON, FRANCE 69003 510(k) STATEMENT
DEVICE: ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
FORTNE MEDICAL INSTRUMENT CORP. 510(k) NO: K014002(TRADITIONAL)
ATTN: ABE WANG PHONE NO : 886 226 360845
12-9, LIN 5, MAO-CHANG VILLAGE SE DECISION MADE: 04-MAR-02
SAN-CHIH HSIANG, 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: XIVE DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K013867(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 15-MAR-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIFIL FLOW
GC AMERICA, INC. 510(k) NO: K020342(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 28-MAR-02
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: CARD IQ ANALYSIS II
GE MEDICAL SYSTEMS 510(k) NO: K020796(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 26-MAR-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DINAMAP PRO 1000 MONITOR, MODEL 1000
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K012915(TRADITIONAL)
ATTN: THOMAS J ENGLISH PHONE NO : 813-887-2107
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 21-MAR-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOSS RESORBABLE BONE VOID FILLER
GEISTLICH-PHARMA 510(k) NO: K014289(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378
1050 CONNECTICUT AVE. N.W. SE DECISION MADE: 28-MAR-02
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: PATIENTNET MONITORING SYSTEM
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K020524(SPECIAL)
ATTN: DIANA M THORSON PHONE NO : 800-888-0077
15222 DEL AMO AVENUE SE DECISION MADE: 20-MAR-02
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
GETINGE/CASTLE, INC. 510(k) NO: K020590(SPECIAL)
ATTN: FREDERICK R CATT PHONE NO : 716-272-5013
1777 EAST HENRIETTA RD. SE DECISION MADE: 20-MAR-02
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XX
GIMMI GMBH 510(k) NO: K012869(ABBREVIATED)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 11-MAR-02
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYD
GUIDANT CORP. 510(k) NO: K020340(SPECIAL)
ATTN: JENNIFER PAE RIGGS PHONE NO : 909-914-4581
26531 YNEZ RD. SE DECISION MADE: 01-MAR-02
TEMECULA, CA 92591-4628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIEGO POWERED DISSECTOR AND DRILL SYSTEM
GYRUS ENT L.L.C. 510(k) NO: K020594(TRADITIONAL)
ATTN: GREGORY SREDIN PHONE NO : 901-373-0200
2925 APPLING RD SE DECISION MADE: 08-MAR-02
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERRALENE, MODEL CATALOG NO 1S
H & A CONSULTANTS 510(k) NO: K020265(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414
2584 SADDLEWOOD LANE SE DECISION MADE: 08-MAR-02
PALM HARBOR, FL 34685 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOPSY
HAKKO MEDICAL CO., LTD. 510(k) NO: K013109(TRADITIONAL)
ATTN: SHIRO JITAGAWA PHONE NO : 81 3 4648500
7-9 KAMIMEGURO 1-CHOME SE DECISION MADE: 12-MAR-02
MEGURO-KU, TOKYO, JAPAN 153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMARQER
HAMILTON THORNE RESEARCH 510(k) NO: K012805(TRADITIONAL)
ATTN: DIARMAID DOUGLAS-HAMITON PHONE NO : 978-921-2050
100 CUMMINGS CENTER SE DECISION MADE: 13-MAR-02
SUITE 102-C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: GREAT TOE IMPLANT SYSTEM
HARMOS ORTHOPAEDICS, INC. 510(k) NO: K014164(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 410-744-8367
1002 FREDERICK ROAD SE DECISION MADE: 12-MAR-02
CATONSVILLE, MD 21228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
HELENA LABORATORIES 510(k) NO: K020467(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 29-MAR-02
BEAUMONT, TX 77704 510(k) STATEMENT
DEVICE: HIGHGATE CURVED ROD SYSTEM
HIGHGATE ORTHOPAEDICS 510(k) NO: K012045(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 12-MAR-02
CHESTERLAND, OH 44026-2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTO
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K014240(TRADITIONAL)
ATTN: ROBERT MCCARTHY PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 22-MAR-02
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCARE PELVIC FLOOR THERAPY SYSTEM
HOLLISTER, INC. 510(k) NO: K013612(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 19-MAR-02
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRES
HOLLISTER, INC. 510(k) NO: K013653(TRADITIONAL)
ATTN: CINDY ROBERTS PHONE NO : 847-918-3497
2000 HOLLISTER DR. SE DECISION MADE: 05-MAR-02
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEGUARD SAFETY INFUSION SET
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K013871(TRADITIONAL)
ATTN: PATRICIA D JONES PHONE NO : 706-846-3126
1 HORIZON WAY SE DECISION MADE: 29-MAR-02
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT ELEVATED RIM LINER
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020497(SPECIAL)
ATTN: NANCY J RIEDER PHONE NO : 201-934-4364
59 ROUTE 17 SE DECISION MADE: 04-MAR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020572(SPECIAL)
ATTN: NANCY J RIEDER PHONE NO : 201-934-4364
59 ROUTE 17 SE DECISION MADE: 04-MAR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020650(SPECIAL)
ATTN: WILLIAM J CYMBALUK PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 29-MAR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA 3 LAG SCREW
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020677(SPECIAL)
ATTN: WILLIAM J CYMBALUK PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 29-MAR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWTRON UNIVERSAL, MODEL AC600
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K010744(TRADITIONAL)
ATTN: AUDRY WITKO PHONE NO : 732-578-9898
40 CHRISTOPHER WAY SE DECISION MADE: 26-MAR-02
EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP,
I-FLOW CORP. 510(k) NO: K020660(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 20-MAR-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-FLOW ELASTOMERIC PUMP
I-FLOW CORP. 510(k) NO: K020862(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 26-MAR-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI LINE MARKER
I.Z.I. CORP. 510(k) NO: K014022(TRADITIONAL)
ATTN: HELEN ZINREICH PHONE NO : 410-594-9403
7020 TUDSBURY ROAD SE DECISION MADE: 04-MAR-02
BALTIMORE, MD 21244 510(k) STATEMENT
DEVICE: INVIGRA
INDUS MEDICARE LTD. 510(k) NO: K020223(ABBREVIATED)
ATTN: P. K REDDY PHONE NO : 914 077 60241
144, S.P. RD., BEGUMPET SE DECISION MADE: 04-MAR-02
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT
DEVICE: ACT 11 MP VENTRICULAR CATHETER
INNERSPACE, INC. 510(k) NO: K013005(TRADITIONAL)
ATTN: DONALD E BOBO PHONE NO : 949-752-8672
2933 SOUTH PULLMAN ST., SE DECISION MADE: 08-MAR-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705
DEVICE: IALUSET HYDROCOLLOID
INSTITUT BIOCHIMIQUE SA (IBSA) 510(k) NO: K020041(TRADITIONAL)
ATTN: CLARENCE E JONES PHONE NO : 714-963-0078
8602 MOSSFORD DRIVE SE DECISION MADE: 14-MAR-02
HUNTINGTON BEACH, CA 92646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
INTEGRA NEUROSCIENCES 510(k) NO: K020558(SPECIAL)
ATTN: NANCY MATHEWSON PHONE NO : 858-455-1115
5955 PACIFIC CENTER BLVD. SE DECISION MADE: 21-MAR-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCHRON JR. SIGNATURE +
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K020798(SPECIAL)
ATTN: JOHN CLAY PHONE NO : 800-272-1252
8 OLSEN AVENUE SE DECISION MADE: 28-MAR-02
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS SEQUESTRATION SYSTEM
INTERPORE CROSS INTL. 510(k) NO: K012406(TRADITIONAL)
ATTN: PROISE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 26-MAR-02
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PISCES PLUS (DW286 C)
IVOCLAR VIVADENT, INC. 510(k) NO: K020183(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 13-MAR-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: D.SIGN 15 (DW286 B)
IVOCLAR VIVADENT, INC. 510(k) NO: K020898(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 29-MAR-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: GLASS POST
J. MORITA USA, INC. 510(k) NO: K012849(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 27-MAR-02
SUITE 500 NORTH 510(k) STATEMENT
WASHINGTON, DC 20005
DEVICE: TEMPORARY CROWN AND BRIDGE MATERIAL
J. MORITA USA, INC. 510(k) NO: K020157(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-626-6433
601 13TH STREET, N.W. SE DECISION MADE: 04-MAR-02
WASHINGTON, DC 20005 510(k) STATEMENT
DEVICE: NON-EUGENOL TEMPORARY CEMENT
J. MORITA USA, INC. 510(k) NO: K020158(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 07-MAR-02
WASHINGTON, DC 20005 510(k) STATEMENT
DEVICE: SAFETOUCH
JAMES D RUSIN MD, MBA 510(k) NO: K014300(TRADITIONAL)
ATTN: JAMES D RUSIN PHONE NO : 612-242-8037
3512 RUM RIVER DRIVE SE DECISION MADE: 01-MAR-02
ANOKA, MN 55303-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRARED EAR THERMOMETER, MODEL DX-707
JAWON MEDICAL CO., LTD. 510(k) NO: K013876(TRADITIONAL)
ATTN: WON-HEE PARK PHONE NO : 011 82 25874056
JEONG-JU B/D 7F,1451-38, SE DECISION MADE: 04-MAR-02
SEOCHO-DONG 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 137-070 THIRD PARTY REVIEW
DEVICE: JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
JOSTRA AG 510(k) NO: K014303(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA ROAD SE DECISION MADE: 26-MAR-02
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K-JUMP HEALTH CO., LTD. 510(k) NO: K014204(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN STREET, N.W. SE DECISION MADE: 05-MAR-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILUX 501
KERR CORPORATION (DANBURY) 510(k) NO: K020091(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 21-MAR-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP MODELING GEL
KERR DENTAL MATERIALS CENTER 510(k) NO: K020178(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 15-MAR-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORB-X RESORBABLE PLATING SYSTEM
KLS-MARTIN L.P. 510(k) NO: K011590(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 20-MAR-02
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONICA DIRECT DIGITIZER REGIUS MODEL 350
KONICA CORP. 510(k) NO: K013054(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 011 815 96373609
319 AKENO, OBATA-CHO SE DECISION MADE: 04-MAR-02
WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA
MIE-KEN, JAPAN 5190501
DEVICE: LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FRE
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K014087(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 04-MAR-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: DYNA INTRA-LIMBAL LENS
LENS DYNAMICS, INC. 510(k) NO: K020006(TRADITIONAL)
ATTN: AL VASKE PHONE NO : 303-237-6927
8600 WEST 14TH AVE., #2 SE DECISION MADE: 29-MAR-02
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTTRENDS
LEV-EL, LTD. 510(k) NO: K012825(TRADITIONAL)
ATTN: EINAT SHAMMAI PHONE NO : 972 499 47880
MIZPE AVIV INDUSTRIAL PARK 13 SE DECISION MADE: 19-MAR-02
M.P. MISGAV, ISRAEL 20187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108
MAINE STANDARDS CO. 510(k) NO: K020450(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 21-MAR-02
SUITE 9A 510(k) SUMMARY AVAILABLE FROM FDA
WINDHAM, ME 04062-5365
DEVICE: JOE LUBE CONDOM
MARKETING SALES CONCEPTS, INC. (MS510(k) NO: K011363(ABBREVIATED)
ATTN: ERIC J ARTHUR PHONE NO : 404-815-4596
200 RENAISSANCE COMPANY SE DECISION MADE: 25-MAR-02
SUITE 111 510(k) STATEMENT
ATLANTA, GA 30308
DEVICE: JOE LUB "HELMET" CONDOM
MARKETING SALES CONCEPTS, INC. (MS510(k) NO: K011378(ABBREVIATED)
ATTN: ERIC J ARTHUR PHONE NO : 404-815-4596
200 RENAISSANCE COMPANY SE DECISION MADE: 25-MAR-02
SUITE 111 510(k) STATEMENT
ATLANTA, GA 30308
DEVICE: MEDELA SYMPHONY BREASTPUMP, MODEL 024
MEDELA, INC. 510(k) NO: K020518(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 41 41 7695228
LAETTICHSTRASSE 4B SE DECISION MADE: 07-MAR-02
BARR, ZUG, SWITZERLAND 6341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WIZAIR DVT
MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K012994(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 9 7718130
117 AHUZAH ST. SE DECISION MADE: 27-MAR-02
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIG
MEDTRONIC MIDAS REX 510(k) NO: K020069(TRADITIONAL)
ATTN: GREG CANNEDY PHONE NO : 817-788-6503
4620 NORTH BEACH STREET SE DECISION MADE: 18-MAR-02
FORT WORTH, TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERGRAFT RESORBABLE CERAMIC GRANULES
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K012506(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 07-MAR-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENGUARD REMOTE PATIENT MONITOR
MENNEN MEDICAL LTD. 510(k) NO: K020632(SPECIAL)
ATTN: ASHER KASSEL PHONE NO : 972 8 9383030
KIRYAT WEIZMANN SCIENCE PARK SE DECISION MADE: 15-MAR-02
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: PRIME ECG SYSTEM
MERIDIAN MEDICAL TECHNOLOGIES, INC510(k) NO: K012414(TRADITIONAL)
ATTN: JAMIL F LAHAM PHONE NO : 410-309-6830
10240 OLD COLUMBIA RD. SE DECISION MADE: 06-MAR-02
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C,
MESURE TECHNOLOGY 510(k) NO: K013779(TRADITIONAL)
ATTN: PHIL ZULUETA PHONE NO : 661-269-1006
34138 COURTNEY TERRACE SE DECISION MADE: 29-MAR-02
ACTON, CA 93510 510(k) STATEMENT
DEVICE: MICROAIRE 1000E SYSTEM
MICROAIRE SURGICAL INSTRUMENTS, IN510(k) NO: K014060(TRADITIONAL)
ATTN: CARL ANGLES PHONE NO : 434-975-8000
1641 EDLICH DR. SE DECISION MADE: 05-MAR-02
CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
MICROLIFE CORP. 510(k) NO: K020725(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 12-MAR-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: PERIOLASE ND:YAG DENTAL LASER SYSTEM
MILLENNIUM DENTAL TECHNOLOGIES, IN510(k) NO: K014272(TRADITIONAL)
ATTN: DAVID M HARRIS PHONE NO : 510-583-7574
4256 HEYER AVENUE SE DECISION MADE: 27-MAR-02
CASTRO VALLEY, CA 94546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRISTORE FIXATOR
MILLENNIUM MEDICAL TECHNOLOGIES, I510(k) NO: K012294(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 04-MAR-02
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: MITEK BIOCRYL INTERFERENCE SCREWS
MITEK PRODUCTS 510(k) NO: K013572(SPECIAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 14-MAR-02
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAT ACTIVE WHEELCHAIR
MOVINGPEOPLE.NET 510(k) NO: K020737(TRADITIONAL)
ATTN: PEGGY SPILIADIS PHONE NO : 416 739 8333
500 NORTINCH DRIVE SE DECISION MADE: 21-MAR-02
TORONTO, ONTARIO, CANADA M3N 1Y4 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: NVA-63-8 NEUROVASCULAR ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K020606(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 13-MAR-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MTP CLEARVISION DISPOSABLE TUBING SET
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K020599(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 13-MAR-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTOFLO
NATS CORP. 510(k) NO: K020060(ABBREVIATED)
ATTN: RICHARD C LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 05-MAR-02
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMA
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K012891(TRADITIONAL)
ATTN: RONALD J EHMSEN PHONE NO : 925-463-4371
4280 HACIENDA DR. SE DECISION MADE: 07-MAR-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002,
NEOTHERMIA CORP. 510(k) NO: K020031(TRADITIONAL)
ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 27-MAR-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREFERNCE IMRT TREATMENT PLANNING MODULE
NORTHWEST MEDICAL PHYSICS EQUIPMEN510(k) NO: K012575(TRADITIONAL)
ATTN: LEE MYERS PHONE NO : 425-672-2841
21031 67TH AVE. WEST SE DECISION MADE: 12-MAR-02
LYNNWOOD, WA 98036 510(k) STATEMENT
DEVICE: MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
NOTAL VISION, INC. 510(k) NO: K014044(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PKWAY; STE 625 SE DECISION MADE: 04-MAR-02
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NTERO HOTROD SYSTEM
NTERO SURGICAL, INC. 510(k) NO: K014251(TRADITIONAL)
ATTN: BOMMI BOMMANNAN PHONE NO : 650-428-1000
1137D SAN ANTONIO RD. SE DECISION MADE: 26-MAR-02
PALO ALTO, CA 94303-4310 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSPECTQUAD GAMMA CAMERA
NUCLEAR CARDIOLOGY SYSTEMS, INC. 510(k) NO: K013353(TRADITIONAL)
ATTN: CHARLES H ROSE PHONE NO : 303-541-0044
5660 AIRPORT BLVD., SUITE 101 SE DECISION MADE: 04-MAR-02
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT GUIDANCE SYSTEM APPLICATOR SET
NUCLETRON CORP. 510(k) NO: K020015(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 13-MAR-02
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE TRIAD FACET SCREW SYSTEM
NUVASIVE, INC. 510(k) NO: K020411(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-527-1918
10065 OLD GROVE RD. SE DECISION MADE: 12-MAR-02
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESE
NXSTAGE MEDICAL, INC. 510(k) NO: K011269(TRADITIONAL)
ATTN: KAREN ST. ONGE PHONE NO : 978-687-4700
439 SOUTH UNION STREET SE DECISION MADE: 05-MAR-02
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
S. LAWRENCE, MA 01843
DEVICE: STAURENGHI WIDE FIELD SCANNING LASER LENS
OCULAR INSTRUMENTS, INC. 510(k) NO: K014170(TRADITIONAL)
ATTN: RAYMOND GRAHAM PHONE NO : 425-455-5200
2255 116TH AVE., N.E. SE DECISION MADE: 04-MAR-02
BELLEVUE, WA 98004-3039 510(k) STATEMENT
DEVICE: SALUTE, MODEL 3022
ONUX MEDICAL, INC. 510(k) NO: K014286(TRADITIONAL)
ATTN: RUTHANN DEPIETRO PHONE NO : 603-929-6200
5 MERRILL DR. SE DECISION MADE: 08-MAR-02
HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS
OPTONOL, LTD 510(k) NO: K012852(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PKWY, STE 625 SE DECISION MADE: 26-MAR-02
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTAFLEX SURGICAL MESH
ORGANOGENESIS, INC. 510(k) NO: K020049(TRADITIONAL)
ATTN: PATRIC BILBO PHONE NO : 781-401-1155
150 DAN RD. SE DECISION MADE: 18-MAR-02
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODI TALON INTRAMEDULLARY HIP NAIL
ORTHOPEDIC DESIGNS, INC. 510(k) NO: K014189(TRADITIONAL)
ATTN: JOHN SODEIKA PHONE NO : 727-343-0338
6965 1ST AVE., NORTH SE DECISION MADE: 21-MAR-02
ST. PETERSBURG, FL 33710-8303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B,
OSCOR INC. 510(k) NO: K020669(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 28-MAR-02
PALM HARBOR, FL 34683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMACHILLER 4
PARADIGM TREX, LLC 510(k) NO: K014253(TRADITIONAL)
ATTN: NIKOLAI TANKOVICH PHONE NO : 858-646-5721
10455 PACIFIC CENTER CT. SE DECISION MADE: 26-MAR-02
SAN DIEGO, CA 92121-4339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOUCH&BOND-PLUS;
PARKELL, INC. 510(k) NO: K020239(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 20-MAR-02
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K020331(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST 42ND AVE. SE DECISION MADE: 20-MAR-02
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVICFLEXER EXERCISE DEVICE
PELVICFLEX, INC. 510(k) NO: K011688(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 20-MAR-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: NORAPAD PLAIN; NORAPAD TA
PERLEI MEDICAL, INC. 510(k) NO: K014268(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 27-MAR-02
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
PHILIPS MEDICAL SYSTEMS 510(k) NO: K020055(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 15-MAR-02
BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT
PHILIPS MEDICAL SYSTEMS 510(k) NO: K020531(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 20-MAR-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
PISHARODI SURGICALS, INC. 510(k) NO: K014302(TRADITIONAL)
ATTN: MADHAVEN PISHARODI PHONE NO : 956-541-6725
942 WILDROSE LANE SE DECISION MADE: 29-MAR-02
BROWNSVILLE, TX 78520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAYTEX DEODORANT TAMPONS, MODEL 34802
PLAYTEX PRODUCTS, INC. 510(k) NO: K020200(TRADITIONAL)
ATTN: MARK ROSENGARTEN PHONE NO : 201-785-8040
75 COMMERCE DR. SE DECISION MADE: 13-MAR-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAYTEX DEODORANT TAMPONS, MODEL 34902
PLAYTEX PRODUCTS, INC. 510(k) NO: K020201(TRADITIONAL)
ATTN: MARK ROSENGARTEN PHONE NO : 201-785-8040
75 COMMERCE DR. SE DECISION MADE: 12-MAR-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAYTEX DEODORANT TAMPONS, MODEL 34702
PLAYTEX PRODUCTS, INC. 510(k) NO: K020202(TRADITIONAL)
ATTN: MARK ROSENGARTEN PHONE NO : 201-785-8040
75 COMMERCE DR. SE DECISION MADE: 12-MAR-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
POREX SURGICAL, INC. 510(k) NO: K012350(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 14-MAR-02
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVS 1500 SDS
PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K020733(TRADITIONAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1736
2405 WEST ORTON CIR. SE DECISION MADE: 21-MAR-02
WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROCERA ALLCERAM BRIDGE MATERIAL
PROCERA SANDVIK AB 510(k) NO: K020269(TRADITIONAL)
ATTN: AGNETA ODEN PHONE NO : 468 726 6619
LERKROGSVAGEN 19 VASTBERGA SE DECISION MADE: 27-MAR-02
STOCKHOLM, SWEDEN S-12680 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFYRE SLING SYSTEM
PROMEDON 510(k) NO: K020007(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 MAIN STREET SE DECISION MADE: 21-MAR-02
ESSEX JUNCTION, VT 05452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
PULPDENT CORP. 510(k) NO: K014133(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 14-MAR-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
PULPDENT CORP. 510(k) NO: K014138(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 14-MAR-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
QUANTIMETRIX CORP. 510(k) NO: K013662(SPECIAL)
ATTN: GEBHARD NEYER PHONE NO : 310-536-0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 08-MAR-02
REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 6
REGULATORY INSIGHT, INC. 510(k) NO: K020094(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 08-MAR-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 80
REGULATORY INSIGHT, INC. 510(k) NO: K020100(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 08-MAR-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
RESPIRONICS, INC. 510(k) NO: K020777(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LANE SE DECISION MADE: 20-MAR-02
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIABETES ASSISTANT SOFTWARE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K014139(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 21-MAR-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS ANTI-TG CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020369(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 06-MAR-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS VALUE HCG
SA SCIENTIFIC, INC. 510(k) NO: K020438(ABBREVIATED)
ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 08-MAR-02
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SANARUS VISICA TREATMENT SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K020605(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 08-MAR-02
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURA
SCIENCE INCORPORATED 510(k) NO: K020881(SPECIAL)
ATTN: LYNN WEIST PHONE NO : 952-835-1333
12150 NICOLLET AVENUE SOUTH SE DECISION MADE: 27-MAR-02
BURNSVILLE, MN 55337-1647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI OXYGEN SYSTEM, MODEL 1000
SEQUAL TECHNOLOGIES, INC. 510(k) NO: K013931(TRADITIONAL)
ATTN: PAM JACKSON PHONE NO : 858-202-3100
11436 SORRENTO VALLEY RD. SE DECISION MADE: 27-MAR-02
SAN DIEGO, CA 92121-1393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINA
SIAM SEMPERMED CORP. LTD. 510(k) NO: K013267(TRADITIONAL)
ATTN: KATIE LEVINSON PHONE NO : 727-787-7250
30798 US HWY 19 NORTH SE DECISION MADE: 08-MAR-02
PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K020573(TRADITIONAL)
ATTN: JAMES YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 13-MAR-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOONRAY MOBILE C-ARM
SIMAD S.R.L. 510(k) NO: K013426(TRADITIONAL)
ATTN: JEFFREY S KEES PHONE NO : 937-382-1451
70 WEIL WAY SE DECISION MADE: 26-MAR-02
WILMINGTON, OH 45177 510(k) STATEMENT
DEVICE: VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPON
SMITH & NEPHEW, INC. 510(k) NO: K012778(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 15-MAR-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPON
SMITH & NEPHEW, INC. 510(k) NO: K012787(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 15-MAR-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPON
SMITH & NEPHEW, INC. 510(k) NO: K012788(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 15-MAR-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW TWINFIX TI QUICK T
SMITH & NEPHEW, INC. 510(k) NO: K020159(TRADITIONAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-261-3658
160 DASCOMB RD. SE DECISION MADE: 26-MAR-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RBM
SMITH & NEPHEW, INC. 510(k) NO: K020480(SPECIAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-261-3770
130 FORBES BLVD. SE DECISION MADE: 12-MAR-02
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
SOPHYSA SA 510(k) NO: K013488(TRADITIONAL)
ATTN: JACQUELINE E MASSE PHONE NO : 781-239-8108
70 WALNUT STREET SE DECISION MADE: 27-MAR-02
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
SOPRO 510(k) NO: K020270(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 33 4 91270727
PLACE ST. CHRISTOPHE SE DECISION MADE: 14-MAR-02
LES ACCATES-LA VALENTINE 510(k) STATEMENT
MARSEILLE, FRANCE 13011
DEVICE: UNIVERSAL BONE PLATE III SYSTEM (UBP III)
SPINAL CONCEPTS, INC. 510(k) NO: K020611(SPECIAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 27-MAR-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
SSL AMERICAS, INC. 510(k) NO: K020659(SPECIAL)
ATTN: JOYCE NING PHONE NO : 770-582-2152
3585 ENGINEERING DR.; STE 200 SE DECISION MADE: 29-MAR-02
P.O. BOX 926090 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092-9214
DEVICE: INTEGRAPH FLASH, MODEL CI 110
STERITEC PRODUCTS, INC. 510(k) NO: K012732(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 04-MAR-02
CASTLE ROCK, CO 80104 510(k) STATEMENT
DEVICE: STERN MICRO ERA ATTACHMENT SYSTEM
STERNGOLD 510(k) NO: K020391(SPECIAL)
ATTN: MARIA RAO PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 08-MAR-02
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K020097(TRADITIONAL)
ATTN: ALISA MILLER PHONE NO : 408-567-9100
2590 WALSH AVE. SE DECISION MADE: 15-MAR-02
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K014263(SPECIAL)
ATTN: ROBIN L ROWE PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 08-MAR-02
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
SULZER DENTAL, INC. 510(k) NO: K014175(TRADITIONAL)
ATTN: SEAN HARIRI PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 20-MAR-02
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER DENTAL CERAMIC SYSTEM-SPLINE
SULZER DENTAL, INC. 510(k) NO: K014214(TRADITIONAL)
ATTN: SEAN HARIRI PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 19-MAR-02
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE BARBITURATES DIPSTRIP TEST
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K020136(TRADITIONAL)
ATTN: MING SUN PHONE NO : 856-401-1080
604 VPR CENTER SE DECISION MADE: 20-MAR-02
1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012
DEVICE: STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING C
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K014230(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 72328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 13-MAR-02
BUKIT RAHMAN PUTRA 510(k) STATEMENT
SUNGAI BULOH, SELANGOR, MALAYSIA 47000
DEVICE: CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH
SUPERMAX SDN BHD 510(k) NO: K013774(TRADITIONAL)
ATTN: PRISCILLA WEE PHONE NO : 603 615 72328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 05-MAR-02
BUKIT RAHMAN PUTRA 510(k) STATEMENT
SUNGAI PELONG, SELANGOR, MALAYSIA 47000
DEVICE: SURETONE
SURETONE INTERNATIONAL 510(k) NO: K011588(TRADITIONAL)
ATTN: MARYNA BURKE PHONE NO : 272 193 98251
2 PRESEDENT BRAND STREET SE DECISION MADE: 28-MAR-02
PANORAMA 510(k) STATEMENT
CAPE TOWN, CAPE, SOUTH AFRICA 7500
DEVICE: EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
SURGILIGHT, INC. 510(k) NO: K020973(TRADITIONAL)
ATTN: TIMOTHY SHEA PHONE NO : 407-482-4555
12001 SCIENCE DRIVE SE DECISION MADE: 29-MAR-02
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
ORLANDO, FL 32826
DEVICE: MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SY
SURX, INC. 510(k) NO: K020126(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 925-398-4521
2675 COLLIER CANYON RD. SE DECISION MADE: 15-MAR-02
LIVERMORE, CA 94550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILUX CURING LIGHTS
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K020267(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 29-MAR-02
ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
SYNTHES (USA) 510(k) NO: K014197(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 21-MAR-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K020188(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 08-MAR-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K020472(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 08-MAR-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: URS-IG (GLUCOSE TEST)
TECO DIAGNOSTICS 510(k) NO: K020175(TRADITIONAL)
ATTN: OLIVIA CHEN PHONE NO : 714-693-7788
1268 . LAKEVIEW AVE. SE DECISION MADE: 21-MAR-02
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
TELEMED SYSTEMS, INC. 510(k) NO: K013737(SPECIAL)
ATTN: MICHAEL CARROLL PHONE NO : 978-567-9033
8 KANE INDUSTRIAL DRIVE SE DECISION MADE: 01-MAR-02
HUDSON, MA 01749 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE HAMMER MODEL H100
TENACORE HOLDINGS, INC. 510(k) NO: K012041(TRADITIONAL)
ATTN: BRAND CASO PHONE NO : 949-362-1350
23266 VIA RONDA SE DECISION MADE: 28-MAR-02
MISSION VIEJO,, CA 92691 510(k) STATEMENT
DEVICE: TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
TISSUELINK MEDICAL, INC. 510(k) NO: K014260(TRADITIONAL)
ATTN: VICKI ANASTASI PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 27-MAR-02
SUITE #400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: O-RING PROSTHETIC ATTACHMENT
TITAN IMPLANTS 510(k) NO: K001638(TRADITIONAL)
ATTN: LYNETTE L HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 04-MAR-02
FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT
TOP QUALITY MFG., INC. 510(k) NO: K013821(TRADITIONAL)
ATTN: MARC SINKOW PHONE NO : 215-365-6100
6800 LINDBERGH AVE. SE DECISION MADE: 05-MAR-02
PHILADELPHIA, PA 19142 510(k) STATEMENT
DEVICE: ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW
TRANSONIC SYSTEMS, INC. 510(k) NO: K010253(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300
34 DUTCH MILL RD. SE DECISION MADE: 19-MAR-02
ITHACA, NY 14850-9787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
TRANSWORLD MOBILITY DISTRIBUTION, 510(k) NO: K020001(ABBREVIATED)
ATTN: JUAN C RIVERA PHONE NO : 941-275-6767
6140 MID METRO DRIVE SE DECISION MADE: 21-MAR-02
SUITE #6 510(k) SUMMARY AVAILABLE FROM FDA
FORT MYERS, FL 33912
DEVICE: MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL
TRANSWORLD MOBILITY DISTRIBUTION, 510(k) NO: K020002(ABBREVIATED)
ATTN: JUAN C RIVERA PHONE NO : 941-275-6767
6140 MID METRO DRIVE SE DECISION MADE: 21-MAR-02
SUITE #6 510(k) STATEMENT
FORT MYERS, FL 33912
DEVICE: SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K014259(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 26-MAR-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE
TRIAGE MEDICAL INC 510(k) NO: K014243(TRADITIONAL)
ATTN: BRAD CULBERT PHONE NO : 949-472-0006
13700 ALTON PARKWAY SE DECISION MADE: 26-MAR-02
SUITE 167 510(k) STATEMENT
IRVINE, CA 92618
DEVICE: BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
TRIAGE MEDICAL INC 510(k) NO: K014304(TRADITIONAL)
ATTN: BRAD CULBERT PHONE NO : 949-472-0006
13700 ALTON PARKWAY SE DECISION MADE: 27-MAR-02
SUITE 167 510(k) STATEMENT
IRVINE, CA 92618
DEVICE: MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
U.S. FILTER/IONPURE, INC. 510(k) NO: K013677(SPECIAL)
ATTN: DAVID A DENTINO PHONE NO : 978-614-7359
10 TECHNOLOGY DRIVE SE DECISION MADE: 08-MAR-02
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
UNIVEC, INC. 510(k) NO: K020500(TRADITIONAL)
ATTN: R. COHEN PHONE NO : 631-777-2000
22 DUBON CT. SE DECISION MADE: 19-MAR-02
FARMINGDALE, NY 11735 510(k) STATEMENT
DEVICE: DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
UROGYN LTD. 510(k) NO: K014248(TRADITIONAL)
ATTN: EREZ ADIV PHONE NO : 972 361 22254
DIAMOND BLDG.(26TH FL.) 3A SE DECISION MADE: 21-MAR-02
JABOTINSKY ST. 510(k) SUMMARY AVAILABLE FROM FDA
RAMAT-GAN, ISRAEL 52520
DEVICE: KARMA DISCOVERY, MODEL KP40
VESTIL MANUFACTURING CORP. 510(k) NO: K014127(TRADITIONAL)
ATTN: RICH MICHAEL PHONE NO : 219-668-5677
900 GROWTH PARKWAY SE DECISION MADE: 15-MAR-02
ANGOLA, IN 46703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRONIX V3D COLON
VIATRONIX, INC. 510(k) NO: K020658(ABBREVIATED)
ATTN: BAMAN PATTANAYAK PHONE NO : 866-887-4636
25 EAST LOOP RD., SUITE 204 SE DECISION MADE: 07-MAR-02
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-X
VILEX, INC. 510(k) NO: K014154(TRADITIONAL)
ATTN: ABRAHIM LAVI PHONE NO : 412-655-7550
345 OLD CURRY HOLLOW RD. SE DECISION MADE: 18-MAR-02
PITTSBURGH, PA 15236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REBILDA SC
VOCO GMBH 510(k) NO: K014111(TRADITIONAL)
ATTN: EVAN DICK PHONE NO : 314-721-0112
7527 WESTMORELAND AVE. SE DECISION MADE: 06-MAR-02
ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTADUR P 4
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K020190(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 13-MAR-02
PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMIDUR S2
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K020192(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 15-MAR-02
PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMIDUR KF PLUS
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K020194(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 15-MAR-02
PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMIDUR S1S
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K020195(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 15-MAR-02
PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
WOODSIDE BIOMEDICAL, INC. 510(k) NO: K020180(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 21-MAR-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC CAMERA TC804/C4
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K014158(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 14-MAR-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC CAMERA MC404/C3
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K020336(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 14-MAR-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE UNICONDYLAR KNEE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K014171(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 15-MAR-02
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL
XTRAK MEDICAL INC. 510(k) NO: K013473(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 06-MAR-02
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTODIMER ASSAY MODEL # 1431
XTRANA, INC. 510(k) NO: K012755(TRADITIONAL)
ATTN: PATRICK J O'LEARY PHONE NO : 805-654-0643
6025 NICOLLE STREET SE DECISION MADE: 15-MAR-02
VENTURA, CA 510(k) STATEMENT
DEVICE: ZOLL PAD
ZOLL MEDICAL CORP. 510(k) NO: K011388(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 781-229-0020
32 SECOND AVE. SE DECISION MADE: 25-MAR-02
BURLINGTON, MA 01803 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 289
TOTAL WITH SUMMARIES 235
TOTAL WITH STATEMENTS 54
Updated 11/26/2002
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