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510(k)s Final Decisions Rendered for July 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-JUL-2002 THROUGH 31-JUL-2002
DEVICE: AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950
AARON MEDICAL INDUSTRIES 510(k) NO: K021817(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 11-JUL-02
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMB
ABBOT LABORATORIES 510(k) NO: K021874(TRADITIONAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
200 ABBOTT PARK ROAD SE DECISION MADE: 12-JUL-02
ABBOTT PARK, IL 60064-6187 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
ABX DIAGNOSTICS 510(k) NO: K022200(SPECIAL)
ATTN: TIM LAWTON PHONE NO : 33 467 147320
PARC EUROMEDECINE SE DECISION MADE: 29-JUL-02
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, FRANCE 34184
DEVICE: ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
ACCULASER, INC. 510(k) NO: K020657(TRADITIONAL)
ATTN: PASTY J TRISLER PHONE NO : 202-835-1346
815 CONNECTICUT AVENUE, N.W. SE DECISION MADE: 29-JUL-02
SUITE 610 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
ACMI CORPORATION 510(k) NO: K012018(TRADITIONAL)
ATTN: FRANK J FUCILE PHONE NO : 508-804-2632
136 TURNPIKE ROAD SE DECISION MADE: 16-JUL-02
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
ACON LABORATORIES, INC. 510(k) NO: K021526(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-JUL-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST FUSION PLATE
ACUMED, INC. 510(k) NO: K021321(TRADITIONAL)
ATTN: CARRIE MCMICHAEL PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 17-JUL-02
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYPRESS ULTRASOUND SYSTEM
ACUSON CORP. 510(k) NO: K021497(SPECIAL)
ATTN: BOB LEIKER PHONE NO : 650-694-5080
1220 CHARLESTON RD. SE DECISION MADE: 09-JUL-02
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q LAB SOFTWARE
ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K021966(TRADITIONAL)
ATTN: SARAH BAXTER PHONE NO : 425-487-7665
22100 BOTHELL-EVERETT HWY. SE DECISION MADE: 02-JUL-02
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003 THIRD PARTY REVIEW
DEVICE: HEARTLINE RECEIVING STATION
AEROTEL MEDICAL SYSTEMS (1998) LTD510(k) NO: K022073(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377ROUTE 17 S SE DECISION MADE: 24-JUL-02
HASBROUCK HEIGHT, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEARCH EVOLUTION TOTAL KNEE SYSTEM
AESCULAP, INC. 510(k) NO: K021313(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 22-JUL-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPILOT HTO MODULE
AESCULAP, INC. 510(k) NO: K021327(TRADITIONAL)
ATTN: GEORGE KELLER PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 25-JUL-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART PECTORALIS IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K021337(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 03-JUL-02
PASOROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART CHIN IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K021417(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
3545 AIRWAY DRIVE SE DECISION MADE: 02-JUL-02
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
RENO, NV 89511
DEVICE: AART NASAL IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K021418(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
3545 AIRWAY DRIVE SE DECISION MADE: 02-JUL-02
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
RENO, NV 89511
DEVICE: AART MALAR IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K021419(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
3545 AIRWAY DRIVE SE DECISION MADE: 02-JUL-02
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
RENO, NV 89511
DEVICE: AART SILICONE CARVING BLOCK
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K021820(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 16-JUL-02
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART GLUTEAL IMPLANT
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K021839(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 16-JUL-02
PASOROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
AGION TECHNOLOGIES, LLC. 510(k) NO: K021383(TRADITIONAL)
ATTN: PAUL C FORD PHONE NO : 781-224-7016
60 AUDUBON ROAD SE DECISION MADE: 17-JUL-02
WAKEFIELD, MA 01880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
ALBERT BROWNE LTD. 510(k) NO: K002741(TRADITIONAL)
ATTN: CYNTHIA J.M.NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 03-JUL-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARM AUTOMATIC REPROCESSING MACHINE
ALCAVIS INTERNATIONAL INCORPORATED510(k) NO: K013713(TRADITIONAL)
ATTN: LUDOVICO GIAVOTTO PHONE NO : 301-759-7597
8-8 METROPOLITAN CT. SE DECISION MADE: 15-JUL-02
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITI
ALCON LABORATORIES, INC. 510(k) NO: K021566(TRADITIONAL)
ATTN: MICHAEL BUENGER PHONE NO : 817-551-6810
6201 SOUTH FREEWAY SE DECISION MADE: 02-JUL-02
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K020818(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 05-JUL-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, US
ALOKA CO., LTD. 510(k) NO: K020668(ABBREVIATED)
ATTN: KELVIN BURROUGHS PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 10-JUL-02
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
ALPHATEC MFG., INC. 510(k) NO: K020356(TRADITIONAL)
ATTN: ELLEN A HICKS PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO SE DECISION MADE: 23-JUL-02
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 'RAPIDTEC' 5A MULTIPLE DIP TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K021114(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4737
9110 RED BRANCH ROAD SE DECISION MADE: 23-JUL-02
COLUMBIA, MD 21945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
AMERICAN OPTISURGICAL, INC. 510(k) NO: K020527(TRADITIONAL)
ATTN: NANETTE CANEPA PHONE NO : 949-580-1266
25501 ARCTIC OCEAN SE DECISION MADE: 09-JUL-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SURE STEP MDMA (ECSTASY) DRUG SCREEN TEST
APPLIED BIOTECH, INC. 510(k) NO: K022189(SPECIAL)
ATTN: STEVE WORCESTER PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 19-JUL-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: CRANIAL STEREOTACTIC EQUIPMENT
ARPLAY MEDICAL S.A. 510(k) NO: K010065(TRADITIONAL)
ATTN: RICHARD BORGI PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX SE DECISION MADE: 02-JUL-02
IZEURE, COTE D'OR, FRANCE 21110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
ASAHI MEDICAL CO., LTD 510(k) NO: K013418(TRADITIONAL)
ATTN: DAVID L WEST PHONE NO : 301-272-3113
1801 ROCKVILLE PIKE SE DECISION MADE: 09-JUL-02
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852-1632
DEVICE: V-2100G ADVANCED INFANT INCUBATOR
ATOM MEDICAL CORP. 510(k) NO: K021809(ABBREVIATED)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 18-JUL-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVOX FREEHANDS HME, MODEL 7710
ATOS MEDICAL AB 510(k) NO: K022125(SPECIAL)
ATTN: EDDY ABERG PHONE NO : 464 620 0819
KRAFTGATAN 8 SE DECISION MADE: 30-JUL-02
P.O.BOX 183 510(k) SUMMARY AVAILABLE FROM FDA
HORBY, SWEDEN SE-242 22
DEVICE: BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
AUGUSTINE MEDICAL, INC. 510(k) NO: K021473(TRADITIONAL)
ATTN: SCOTT D AUGUSTINE PHONE NO : 952-947-1200
10393 WEST 70TH ST. SE DECISION MADE: 09-JUL-02
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVID-NIT NERVE STIMULATION NEEDLES
AVID N.I.T., INC. 510(k) NO: K014246(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 813-818-8705
390 SCARLET BLVD. SE DECISION MADE: 16-JUL-02
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: CHEMWELL, ALSO KNOWN AS PROJECT 2900
AWARENESS TECHNOLOGY, INC. 510(k) NO: K013420(ABBREVIATED)
ATTN: GLEN VAN SLOOTEN PHONE NO : 561-283-6540
1995 S.W. MARTIN HWY. SE DECISION MADE: 19-JUL-02
P.O. BOX 1679 510(k) STATEMENT
PALM CITY, FL 34990
DEVICE: DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K021516(TRADITIONAL)
ATTN: EILEEN MCCAFFERTY PHONE NO : 44 138 2422000
THE TECHNOLOGY PARK SE DECISION MADE: 23-JUL-02
LUNA PLACE 510(k) STATEMENT
DUNDEE, SCOTLAND, UNITED KINGDOM DD2 1XA
DEVICE: INTROCAN SAFETY IV CATHETER
B. BRAUN MEDICAL, INC. 510(k) NO: K021094(TRADITIONAL)
ATTN: PATRICIA D WILSON PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 03-JUL-02
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURECAN SAFETY HUBER NEEDLE INFUSION SETS
B. BRAUN MEDICAL, INC. 510(k) NO: K021488(TRADITIONAL)
ATTN: SHERI L MASGNUNG PHONE NO : 610-596-2375
901 MARCON BLVD. SE DECISION MADE: 08-JUL-02
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSI
BACCHUS VASCULAR, INC. 510(k) NO: K021958(SPECIAL)
ATTN: GREG MATHINSON PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 03-JUL-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTZ NEEDLE
BALLARD MEDICAL PRODUCTS 510(k) NO: K013892(TRADITIONAL)
ATTN: SYDNEE F MCMILLAN PHONE NO : 801-572-6800
12050 LONE PEAK PKWY. SE DECISION MADE: 11-JUL-02
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL ADMINISTRATOR
BARCO NV 510(k) NO: K020073(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O. BOX 12038 SE DECISION MADE: 12-JUL-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
BAYER CORP. 510(k) NO: K020828(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 24-JUL-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
BAYER CORP. 510(k) NO: K021428(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 05-JUL-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER RAPIDPOINT 405 SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K020616(TRADITIONAL)
ATTN: THOMAS F FLYNN PHONE NO : 508-359-3877
63 NORTH STREET SE DECISION MADE: 17-JUL-02
MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K020792(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 11-JUL-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K020794(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 11-JUL-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K021151(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 13-JUL-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
BD 510(k) NO: K021475(TRADITIONAL)
ATTN: PASQUALE AMATO PHONE NO : 201-847-4513
1 BECTON DR. MC 226 SE DECISION MADE: 19-JUL-02
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYS
BECKMAN COULTER, INC. 510(k) NO: K021572(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 19-JUL-02
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 660563
BECKMAN COULTER, INC. 510(k) NO: K022161(SPECIAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVENUE SE DECISION MADE: 29-JUL-02
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER PLUS PST II TUBE
BECTON DICKINSON & CO. 510(k) NO: K022130(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 201-847-4717
1 BECTON DRIVE SE DECISION MADE: 29-JUL-02
MC 300 510(k) SUMMARY AVAILABLE FROM FDA
FRANKLIN LAKES, NJ 07417-1880
DEVICE: BACTEC MGIT 960 PZA KIT
BECTON, DICKINSON AND COMPANY 510(k) NO: K021582(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 13-JUL-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG
BECTON, DICKINSON AND COMPANY 510(k) NO: K022129(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 25-JUL-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NO-POKES NEEDLE SAFETY DEVICE
BEMIS MFG. CO. 510(k) NO: K020921(TRADITIONAL)
ATTN: JOHN B HOWELL PHONE NO : 920-467-4621
300 MILL ST. SE DECISION MADE: 11-JUL-02
SHEBOYGAN FALLS, WI 53085 510(k) STATEMENT
DEVICE: PROLITE PULSED LIGHT SYSTEM
BIG SKY LASER TECHNOLOGIES, INC. 510(k) NO: K021304(TRADITIONAL)
ATTN: PATRICK MAINE PHONE NO : 406-586-0131
601 HAGGERTY LN. SE DECISION MADE: 23-JUL-02
P.O. BOX 8100 510(k) SUMMARY AVAILABLE FROM FDA
BOZEMAN, MT 59715
DEVICE: BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K021895(SPECIAL)
ATTN: NORMAN E BRUNNER PHONE NO : 847-949-5200
ONE BIO-LOGIC PLAZA SE DECISION MADE: 01-JUL-02
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROTECH MEDISTIM PLUS, TYPE 291
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K014019(TRADITIONAL)
ATTN: MICHELLE SAWYER PHONE NO : 353 917 74361
PARKMORE BUSINESS PARK, SE DECISION MADE: 11-JUL-02
WEST GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NT MEDITENS PLUS, TYPE 290
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K014020(TRADITIONAL)
ATTN: MICHELLE SAWYER PHONE NO : 353 917 74361
PARKMORE BUSINESS PARK, SE DECISION MADE: 11-JUL-02
WEST GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
BIO-RAD LABORATORIES, INC. 510(k) NO: K022041(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO ROAD SE DECISION MADE: 16-JUL-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS TESTOSTERONE (TES), MODEL 30 418
BIOMERIEUX, INC. 510(k) NO: K021326(TRADITIONAL)
ATTN: KELLY ROWLAND PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 18-JUL-02
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB MINI INTERFERENCE SCREW
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K021254(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 574-267-6639
56 EAS BELL DRIVE SE DECISION MADE: 17-JUL-02
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: PCCS GRAFT DELIVERY SYSTEM
BIOMET, INC. 510(k) NO: K021071(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 219-267-6639
56 EAST BELL DR. SE DECISION MADE: 01-JUL-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL HAMMER TOE PIN
BIOMET, INC. 510(k) NO: K021828(SPECIAL)
ATTN: SARA B SHULTZ PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 01-JUL-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
BIOMET, INC. 510(k) NO: K021927(SPECIAL)
ATTN: LONNIE WITHAM PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 12-JUL-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
BIOMET, INC. 510(k) NO: K022094(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 25-JUL-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC
BIONOSTICS, INC. 510(k) NO: K021624(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON ROAD SE DECISION MADE: 12-JUL-02
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
BIONOSTICS, INC. 510(k) NO: K021697(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON ROAD SE DECISION MADE: 12-JUL-02
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLA
BIOPLATE, INC. 510(k) NO: K022033(SPECIAL)
ATTN: BRUCE F MACKLER PHONE NO :
815 CONNECTICUT AVE NW SE DECISION MADE: 19-JUL-02
WASHINGTON, DC 20006-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
BIOSITE INCORPORATED 510(k) NO: K021317(TRADITIONAL)
ATTN: JEFFERY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 01-JUL-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
BIOTEQUE CORP. 510(k) NO: K013634(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 09-JUL-02
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRA CARDIAC ELECTROSURGICAL SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K013873(TRADITIONAL)
ATTN: ANDREA L RUTH PHONE NO : 408-895-3625
2710 ORCHARD PKWY. SE DECISION MADE: 11-JUL-02
SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE
BOSTON SCIENTIFIC CORP. 510(k) NO: K014297(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5520
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 09-JUL-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIV
BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K021901(SPECIAL)
ATTN: SHERRY L SPARROW PHONE NO : 763-494-2537
ONE SCIMED PLACE SE DECISION MADE: 09-JUL-02
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOLIBRI IGS SYSTEMS
BRAINLAB AG 510(k) NO: K014256(TRADITIONAL)
ATTN: STEFAN VILSMEIER PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 19-JUL-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/T
BRANAN MEDICAL CORP. 510(k) NO: K022355(SPECIAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 30-JUL-02
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02
BROMAC ASSISTIVE TECHNOLOGY 510(k) NO: K021165(TRADITIONAL)
ATTN: DAVID K BROWN PHONE NO : 661-264-2525
15845 SWEETAIRE AVE. SE DECISION MADE: 01-JUL-02
LANCASTER, CA 93535 510(k) STATEMENT
DEVICE: BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
C.R. BARD, INC. 510(k) NO: K021736(TRADITIONAL)
ATTN: BRAIN A KANERVIKO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 16-JUL-02
CANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
CAMBRIDGE HEART, INC. 510(k) NO: K022149(SPECIAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 16-JUL-02
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
CAMBRIDGE HEART, INC. 510(k) NO: K022152(SPECIAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 16-JUL-02
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WISORB MALLEOLAR SCREW
CAMBRIDGE SCIENTIFIC, INC. 510(k) NO: K020222(TRADITIONAL)
ATTN: DEBRA J TRANTOLO PHONE NO : 617-576-2663
180 FAWCETT STREET SE DECISION MADE: 29-JUL-02
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGERY AND ACCESSORIES
CAMTRONICS, LTD. 510(k) NO: K021236(TRADITIONAL)
ATTN: SCOTT PEASE PHONE NO : 262-369-3123
MEDICAL SYSTEMS SE DECISION MADE: 17-JUL-02
900 WALNUT RIDGE DR., BOX 950 510(k) SUMMARY AVAILABLE FROM FDA
HARTLAND, WI 53029
DEVICE: CANDELA VBEAM PULSED DYE LASER SYSTEM
CANDELA CORP. 510(k) NO: K021180(TRADITIONAL)
ATTN: LORRAINE NELSON PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 02-JUL-02
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K021574(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600
2 PEKERIS ST. SE DECISION MADE: 18-JUL-02
PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: MODIFICATION TO CARDEON AEGIS CATHETER
CARDEON CORP. 510(k) NO: K022174(SPECIAL)
ATTN: JANE BEGGS PHONE NO : 408-517-2522
10161 BUBB RD. SE DECISION MADE: 29-JUL-02
CUPERTINO, CA 95014-4133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE LDH
CARESIDE, INC. 510(k) NO: K020484(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 03-JUL-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE GGT
CARESIDE, INC. 510(k) NO: K020486(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 01-JUL-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
CATHAY INTERNATIONAL, LTD. 510(k) NO: K020735(TRADITIONAL)
ATTN: ANNE JEN PHONE NO : 022 591 7938
RM. 8F-3, NO. 29, CHUNGSHAN N. SE DECISION MADE: 12-JUL-02
RD. SEC 3 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN)
DEVICE: D/SENSE 1-STEP
CENTRIX, INC. 510(k) NO: K021146(TRADITIONAL)
ATTN: JOHN DISCKO PHONE NO : 203-929-5582
770 RIVER ROAD SE DECISION MADE: 02-JUL-02
SHELTON, CT 06484-5458 510(k) STATEMENT
DEVICE: CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
CHAD THERAPEUTICS, INC. 510(k) NO: K020475(TRADITIONAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883
21622 PLUMMER ST. SE DECISION MADE: 05-JUL-02
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLAR WAND
CHEK-MED SYSTEMS 510(k) NO: K021387(TRADITIONAL)
ATTN: ROB WHALEN PHONE NO : 717-761-1170
25 VILLAGE HILL ROAD SE DECISION MADE: 31-JUL-02
WILLINGTON, CT 06279 510(k) STATEMENT
DEVICE: QAB2A IGM ELISA KIT HRP
CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K021610(TRADITIONAL)
ATTN: NEIL B STRINGER PHONE NO : 441 513 488023
7 ELM ST. SE DECISION MADE: 12-JUL-02
ELLESMERE PORT 510(k) STATEMENT
CHESHIRE, UNITED KINGDOM CH65 2AU
DEVICE: QAB2A IGG ELISA KIT HRP
CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K021611(TRADITIONAL)
ATTN: NEIL B STRINGER PHONE NO : 441 115 13488023
7 ELM ST. SE DECISION MADE: 12-JUL-02
ELLESMERE PORT 510(k) STATEMENT
CHESHIRE, UNITED KINGDOM CH65 2AU
DEVICE: CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
CLEAR MEDICAL, INC. 510(k) NO: K012600(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 03-JUL-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
CLEAR MEDICAL, INC. 510(k) NO: K012609(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 03-JUL-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
CLEAR MEDICAL, INC. 510(k) NO: K012622(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 03-JUL-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
COALESCENT SURGICAL 510(k) NO: K021407(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 03-JUL-02
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGI
COBE CARDIOVASCULAR, INC. 510(k) NO: K021830(SPECIAL)
ATTN: SHAWN RIEDEL PHONE NO : 303-467-6521
14401 WEST 65TH WAY SE DECISION MADE: 02-JUL-02
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN BACTISEAL EVD CATHETER SET
CODMAN & SHURTLEFF, INC. 510(k) NO: K021653(TRADITIONAL)
ATTN: KATHY WUNDER PHONE NO : 508-880-8351
325 PARAMOUNT DR. SE DECISION MADE: 29-JUL-02
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VP-2000/1000
COLIN CORP. 510(k) NO: K013434(TRADITIONAL)
ATTN: KENICHI SAKURADO PHONE NO : 81 568 79-1122
2007-1 HAYASHI SE DECISION MADE: 09-JUL-02
KOMAKI CITY, AICHI PREF., JAPAN 48510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINDATALINK VERSION 1.0 FOR SPIROMETRY
COMPLEWARE CORP. 510(k) NO: K020004(TRADITIONAL)
ATTN: KAY WEILER PHONE NO : 319-338-8888
221 EAST BURLINGTON ST. SE DECISION MADE: 24-JUL-02
IOWA CITY, IA 52240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
CONCENTRIC MEDICAL, INC. 510(k) NO: K021899(SPECIAL)
ATTN: KEVIN MACDONALD PHONE NO : 650-938-2100
2585 LEGHORN ST. SE DECISION MADE: 10-JUL-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 13
CONMED CORP. 510(k) NO: K021079(TRADITIONAL)
ATTN: CHARLES M HART PHONE NO : 303-699-9854
14603 FREMONT AVE. SE DECISION MADE: 01-JUL-02
CENTENNIAL, CO 80112 510(k) STATEMENT
DEVICE: DELIGHT DENTAL ER: YAG LASER SYSTEM
CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K021616(TRADITIONAL)
ATTN: TOM HANEY PHONE NO : 408-727-3240
3150 CENTRAL EXPRESSWAY SE DECISION MADE: 11-JUL-02
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPLE LUMEN CENTRAL VENOUS CATHETER
COOK, INC. 510(k) NO: K013182(TRADITIONAL)
ATTN: LISA HOPKINS PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 01-JUL-02
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
COPIOUMED INTL., INC. 510(k) NO: K021961(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 02-JUL-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOALIGN
CORTECHS LABS, INC. 510(k) NO: K021191(ABBREVIATED)
ATTN: JEFFREY M ANDERSON PHONE NO : 617-241-9588
6 13TH ST. SE DECISION MADE: 12-JUL-02
CHARLESTOWN, MA 02129-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATER
CP MEDICAL 510(k) NO: K021311(TRADITIONAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 501-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 13-JUL-02
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-ME
CYPRESS MEDICAL PRODUCTS, LTD. 510(k) NO: K021676(TRADITIONAL)
ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100
1202 SOUTH ROUTE 31 SE DECISION MADE: 12-JUL-02
MCHENRY, IL 60050 510(k) STATEMENT
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTA
DADE BEHRING, , INC. 510(k) NO: K020413(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BLVD SE DECISION MADE: 17-JUL-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC WHEELCHAIR, MODEL ELEXUS
DALTON MEDICAL CORP. 510(k) NO: K021199(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-2447
1103 VENTURE CT. SE DECISION MADE: 12-JUL-02
CARROLLTON, TX 75006 510(k) STATEMENT
DEVICE: DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SO
DATEX-OHMEDA 510(k) NO: K021279(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 19-JUL-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A
DATEX-OHMEDA 510(k) NO: K021376(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 24-JUL-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH SPINE SYSTEM
DEPUY ACROMED 510(k) NO: K021335(TRADITIONAL)
ATTN: LISA GILMAN PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 11-JUL-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SY
DEPUY ACROMED 510(k) NO: K022190(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 24-JUL-02
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K021499(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 574-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 24-JUL-02
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TES
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K022118(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 22-JUL-02
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K021394(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 09-JUL-02
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
DIROS TECHNOLOGY, INC. 510(k) NO: K021869(SPECIAL)
ATTN: LESLIE W ORGAN PHONE NO : 843-762-4174
1837 KEMPTON ROAD SE DECISION MADE: 01-JUL-02
CHARLESTON, SC 29412 510(k) STATEMENT
DEVICE: THE DIVACUP MENSTRUAL SOLUTION
DIVA INTERNATIONAL INC 510(k) NO: K021356(TRADITIONAL)
ATTN: FRANCINE CHAMBERS PHONE NO : 519 896 8100
P.O. BOX 25089 SE DECISION MADE: 16-JUL-02
1375 WEBER STREET E 510(k) STATEMENT
KITCHENER ONTARIO, CANADA N2A 4A5
DEVICE: DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
DOLPHIN MEDICAL INC. 510(k) NO: K021959(SPECIAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE SE DECISION MADE: 11-JUL-02
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
DUTECK INDUSTRIAL CO., LTD. 510(k) NO: K021601(TRADITIONAL)
ATTN: YI-LANG LIN PHONE NO : 886 287 975035
3F-2, NO. 26, 513 LANE SE DECISION MADE: 10-JUL-02
JUI-KUANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 114
DEVICE: ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
E. BENSON HOOD LAB, INC. 510(k) NO: K011329(TRADITIONAL)
ATTN: LEWIS MARTEN PHONE NO : 781-826-7573
575 WASHINGTON ST. SE DECISION MADE: 26-JUL-02
PEMBROKE, MA 02359 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
EASTMAN KODAK COMPANY 510(k) NO: K021829(SPECIAL)
ATTN: CAROL RYERSON PHONE NO : 585-724-5910
343 STATE ST. SE DECISION MADE: 02-JUL-02
ROCHESTER, NY 14650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
EASTMAN KODAK COMPANY 510(k) NO: K021903(SPECIAL)
ATTN: PATRICIA B LANZONI PHONE NO : 585-724-3865
1669 LAKE AVE. SE DECISION MADE: 10-JUL-02
ROCHESTER, NY 14652 510(k) STATEMENT
DEVICE: EIZO, MODEL FC-2091
EIZO NANAO CORPORATION 510(k) NO: K022109(TRADITIONAL)
ATTN: YUUICHI SEKI PHONE NO : 817 627 42488
153 SHIMOKASHIWANO, MATTO SE DECISION MADE: 12-JUL-02
ISHIKAWA 924-8566, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATAC PAK BUN REAGENT
ELAN DIAGNOSTICS 510(k) NO: K021385(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD. SE DECISION MADE: 12-JUL-02
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K022119(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 25-JUL-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMT-CPAP
EMERGENCY MEDICAL TECHOLOGY 510(k) NO: K021520(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 15-JUL-02
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: 3D KNEE
ENCORE ORTHOPEDICS, INC. 510(k) NO: K020114(TRADITIONAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 12-JUL-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS TITLE SPINAL FIXATION SYSTEM
ENDIUS, INC. 510(k) NO: K021881(TRADITIONAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 29-JUL-02
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACH VOX
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K013728(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 30-JUL-02
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTENSION SET, MODELS 1911-512
EPIMED INTERNATIONAL, INC. 510(k) NO: K020926(TRADITIONAL)
ATTN: CHRISTOPHER LAKE PHONE NO : 518-725-0209
141 SAL LANDRIO DRIVE SE DECISION MADE: 12-JUL-02
JOHNSTOWN, NY 12095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUINCKE SPINAL NEEDLE
EPIMED INTERNATIONAL, INC. 510(k) NO: K022029(TRADITIONAL)
ATTN: CHRISTOPHER B LAKE PHONE NO : 518-725-0209
141 SAL LANDRIO DRIVE SE DECISION MADE: 30-JUL-02
CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
JOHNSTOWN, NY 12095
DEVICE: INJEX 30 NEEDLE FREE INJECTION SYSTEM
EQUIDYNE SYSTEMS, INC. 510(k) NO: K022148(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 858-451-7001
11770 BERNARDO PLAZA CT. SE DECISION MADE: 23-JUL-02
SUITE 351 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: FIBIOCORE
EST. ANTHOGYR 510(k) NO: K020431(TRADITIONAL)
ATTN: CLAUDE ANTHOINE PHONE NO : 330 450 580237
164 RUE DES TROIS LACS SE DECISION MADE: 03-JUL-02
SALLANCHES, FRANCE 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECHANICAL DAILY USE WHEELCHAIR
FIRST WORLD SERVICES, INC. 510(k) NO: K021075(TRADITIONAL)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVENUE SE DECISION MADE: 12-JUL-02
BALTIMORE, MD 21230 510(k) STATEMENT
DEVICE: RESPIRATORY HUMIDIFIER, MODEL MR850
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K020332(TRADITIONAL)
ATTN: BRETT WHISTON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 03-JUL-02
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERPESELECT 1 ELISA IGG, MODEL EL0910G
FOCUS TECHNOLOGIES, INC. 510(k) NO: K021429(TRADITIONAL)
ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 29-JUL-02
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOSSA URETERAL STONE SWEEPER
FOSSA INDUSTRIES, INC. 510(k) NO: K021602(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 26-JUL-02
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN AN
FRED HUTCHINSON CANCER RESEARCH 510(k) NO: K013263(TRADITIONAL)
ATTN: SHELBY J HALL PHONE NO : 760-635-0892
7914 VIA CALLENDO SE DECISION MADE: 29-JUL-02
CARLSBAD, CA 92009 510(k) STATEMENT
DEVICE: XIVE DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K021318(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 02-JUL-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T
GALIL MEDICAL LTD. 510(k) NO: K021261(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN ST.,N.W. SE DECISION MADE: 03-JUL-02
WASHINGTON, DC 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALT MEDICAL GUIDEWIRE
GALT MEDICAL CORP. 510(k) NO: K021990(SPECIAL)
ATTN: DAVID CATLIN PHONE NO : 972-271-5177
2475 MERRITT DR. SE DECISION MADE: 18-JUL-02
GARLAND, TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K014255(TRADITIONAL)
ATTN: THOMAS ENGLISH PHONE NO : 813-887-2107
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 02-JUL-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE SIM 6.0
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K021780(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 29-JUL-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MAC-LAB/CARDIOLAB EP/COMBOLAB
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K021366(SPECIAL)
ATTN: LISA LEE MICHELS PHONE NO : 262-293-1609
8200 WEST TOWER AVE. SE DECISION MADE: 03-JUL-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENE
GENZYME CORP. 510(k) NO: K021316(TRADITIONAL)
ATTN: BARABRA PIZZA PHONE NO : 617-252-7953
ONE KENDALL SQUARE SE DECISION MADE: 25-JUL-02
CAMBRIDGE, MA 02139-5012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
GLOVCO (M) SDN. BHD. 510(k) NO: K021730(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 329 13888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 05-JUL-02
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR S
GOOD BIOTECH CORP. 510(k) NO: K021757(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 423 596873
38, 34TH RD. SE DECISION MADE: 29-JUL-02
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG CITY, CHINA (TAIWAN) 407
DEVICE: CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
GOOD BIOTECH CORP. 510(k) NO: K021882(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 423 596873
38, 34TH RD. SE DECISION MADE: 11-JUL-02
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG CITY, CHINA
DEVICE: DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 101010
GUIDANT CORP. 510(k) NO: K021824(SPECIAL)
ATTN: MARTHA MURARI PHONE NO : 650-470-6278
1525 O'BRIEN DR. SE DECISION MADE: 02-JUL-02
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
GYRUS MEDICAL, INC. 510(k) NO: K020585(TRADITIONAL)
ATTN: FREDERICK G MADES PHONE NO : 763-416-3000
6655 WEDGWOOD ROAD SE DECISION MADE: 13-JUL-02
MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPCUT
H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K021525(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671
10147 UMBERLAND PLACE SE DECISION MADE: 12-JUL-02
BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
HAYES MEDICAL, INC. 510(k) NO: K021466(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 24-JUL-02
EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT
DEVICE: RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K021194(TRADITIONAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 29-JUL-02
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: MODIFICATION TO RAICHEM CALCIUM REAGENT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K022049(SPECIAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 19-JUL-02
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: CRIT-LINE MONITOR III TQA (CLM TQA)
HEMAMETRICS 510(k) NO: K011741(TRADITIONAL)
ATTN: MATTHEW L HAYNIE PHONE NO : 801-451-9000
695 NORTH, 900 WEST SE DECISION MADE: 23-JUL-02
KAYSVILLE, UT 84037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCEPTRE-VS
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K021314(TRADITIONAL)
ATTN: ROBERT H MCCARTHY PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 02-JUL-02
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZONS CYTOLOGY BRUSH
HORIZONS INTL. CORP. 510(k) NO: K021998(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
P.O. BOX 7273 SE DECISION MADE: 12-JUL-02
PONCE, PR 00732-7273 510(k) STATEMENT
DEVICE: TRIDENT CROSSFIRE POLYUETHYLENE LINERS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K021911(SPECIAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 02-JUL-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022077(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379
59 ROUTE 17 SE DECISION MADE: 25-JUL-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
HYCARE INTL. CO., LTD. 510(k) NO: K020042(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVE. DE LA D'EMERALD SE DECISION MADE: 30-JUL-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER
IDT TECHNOLOGY LIMITED 510(k) NO: K020433(TRADITIONAL)
ATTN: JAMES J ROGERS PHONE NO : 440-546-4936
P.O. BOX 391117 SE DECISION MADE: 11-JUL-02
SOLON, OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-
IMPLEX CORP. 510(k) NO: K021967(SPECIAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 17-JUL-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMME
IMPLEX CORP. 510(k) NO: K021970(SPECIAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 12-JUL-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURE SOFT
IMTEC CORP. 510(k) NO: K021437(TRADITIONAL)
ATTN: BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 19-JUL-02
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCU
INCEPTIO MEDICAL TECHNOLOGIES, LC 510(k) NO: K021984(ABBREVIATED)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
1401 NORTH HIGHWAY 89 SE DECISION MADE: 02-JUL-02
FARMINGTON, UT 84025 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INION HEXALON BIODEGRADABLE ACL/PCL SCREW
INION LTD. 510(k) NO: K021280(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 17-JUL-02
TAMPERE, FINLAND FIN-33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K021482(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 30-JUL-02
SAN DIEGO, CA 92131-1234 510(k) STATEMENT
DEVICE: RESPERATE; MODEL RR-150
INTERCURE LTD. 510(k) NO: K020399(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH STREET N.W. SE DECISION MADE: 02-JUL-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBUMIN REAGENT
INTERSECT SYSTEMS, INC. 510(k) NO: K021636(TRADITIONAL)
ATTN: JOAN CATHEY PHONE NO : 360-577-1062
P.O. BOX 2219 SE DECISION MADE: 17-JUL-02
LONGVIEW, WA 98632 510(k) STATEMENT
DEVICE: ENDOSSOUS IMPLANTS
INTRA-LOCK INTERNATIONAL 510(k) NO: K021322(ABBREVIATED)
ATTN: JEFFERY SAKOFF PHONE NO : 561-447-8282
1200 N. FEDERAL HWY SUITE#200 SE DECISION MADE: 24-JUL-02
BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILT TORQUER, MODEL 114TR1
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K021243(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 11-JUL-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: ILT ADVANCING MECHANISM, MODEL A115AMI
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K021638(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 26-JUL-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
INVACARE CORP. 510(k) NO: K020386(TRADITIONAL)
ATTN: EDWARD A KNOLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 02-JUL-02
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: VENTURE HOMEFILL II WITH OXYGEN CONSERVER
INVACARE CORP. 510(k) NO: K021685(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6000
ONE INVACARE WAY SE DECISION MADE: 23-JUL-02
ELYRIA, OH 44036-2125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYO BIOPSY MEDIUM
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K021358(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 05-JUL-02
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAMPLOK LUER KIT
ITL CORPORATION, PTY LTD. 510(k) NO: K021941(SPECIAL)
ATTN: WILIAM L MOBBS PHONE NO : 61 2 62808535
41-45 TENNANT STREET SE DECISION MADE: 02-JUL-02
FYSHWICK, CANBERRA ACT, AUSTRALIA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHT GOLD
IVOCLAR VIVADENT, INC. 510(k) NO: K021892(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 25-JUL-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: J&S; MEDICAL SENTRY URINE DIPSTICK CONTROL
J & S MEDICAL ASSOC., INC. 510(k) NO: K022085(TRADITIONAL)
ATTN: PAUL MACDONNELL PHONE NO : 800-229-6000
35 TRIPP ST., BLDG. #1 SE DECISION MADE: 25-JUL-02
FRAMINGHAM, MA 01702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K021671(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 19-JUL-02
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K-JUMP HEALTH CO., LTD. 510(k) NO: K021851(ABBREVIATED)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN STREET, N.W. SE DECISION MADE: 17-JUL-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY LP(A) ASSAY
KAMIYA BIOMEDICAL CO. 510(k) NO: K021660(TRADITIONAL)
ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 25-JUL-02
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: INSEMINATION CATHETER, MODEL 320301
LABOTECT LABOR-TECHNIK GOTTINGEN 510(k) NO: K021438(ABBREVIATED)
ATTN: ANGELIKA ALBRECHT PHONE NO : 055 150 505010
WILLI-EICHLER-STR. 25 SE DECISION MADE: 16-JUL-02
GOTTINGEN, GERMANY D-37079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB
LACRIMEDICS, INC. 510(k) NO: K021831(SPECIAL)
ATTN: JERRY HENDERSON PHONE NO : 360-376-7095
310 PRUNE ALLEY SE DECISION MADE: 01-JUL-02
EASTSOUND, WA 98245 510(k) STATEMENT
DEVICE: LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATIO
LASERSCOPE 510(k) NO: K020021(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 408-943-0636
3070 ORCHARD DR. SE DECISION MADE: 02-JUL-02
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE OS TRAUMA
MACROPORE BIOSURGERY, INC. 510(k) NO: K021164(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 01-JUL-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
MAKRITE INDUSTRIES, INC. 510(k) NO: K020474(TRADITIONAL)
ATTN: JOSEPH Z ZDROK PHONE NO : 508-943-4895
24 TOWER ST. SE DECISION MADE: 23-JUL-02
WEBSTER, MA 01570 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELPH INJECTION SYSTEM
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K022116(SPECIAL)
ATTN: ELLIS ROGERS PHONE NO : 513-948-4041
2111 EAST GALBRAITH RD. SE DECISION MADE: 26-JUL-02
CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
MATRITECH, INC. 510(k) NO: K021231(TRADITIONAL)
ATTN: MELODIE R DOMURAD PHONE NO : 617-928-0820
330 NEVADA ST., 2ND FL. SE DECISION MADE: 30-JUL-02
NEWTON, MA 02460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMADERM COTAINING HEMADEX CLOTTING BEADS
MEDAFOR, INC. 510(k) NO: K021678(TRADITIONAL)
ATTN: PHILIP B JARVI PHONE NO : 763-571-6300
5201 EAST RIVER ROAD, # 312 SE DECISION MADE: 12-JUL-02
MINNEAPOLIS, MN 55421-1035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
MEDICA CORP. 510(k) NO: K021515(TRADITIONAL)
ATTN: DEAN HONKONEN PHONE NO : 781-275-4892
14 DEANGELO DR. SE DECISION MADE: 16-JUL-02
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: VERDICT-II
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K022141(SPECIAL)
ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 30-JUL-02
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM ("POLARIS")
MEDTRONIC AVE, INC. 510(k) NO: K022026(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 707-541-3193
2170-A NORTHPOINT PRKWY SE DECISION MADE: 19-JUL-02
SANTA ROSA, CA 95407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K021061(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K021461(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 22-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K021170(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORADO 2 SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K020247(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 22-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERGRAFT RESORBABLE CERAMIC
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K020986(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 22-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K021705(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 24-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K022015(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 18-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K022070(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 22-JUL-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDX 1000 SERIES
MEDX ELECTRONICS, INC. 510(k) NO: K020017(TRADITIONAL)
ATTN: ROBIN WILEY PHONE NO : 703-548-3606
513 BASHFORD LANE SE DECISION MADE: 12-JUL-02
SUITE 5 510(k) SUMMARY AVAILABLE FROM FDA
ALEXANDRIA, VA 22314
DEVICE: VECTORSONIC, MODEL VU-200
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K020119(TRADITIONAL)
ATTN: DAVE TORMAN PHONE NO : 61 3 97751234
57 ASTER AVE. SE DECISION MADE: 22-JUL-02
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: MICOMED POSTERIOR DOUBLEROD SYSTEM
MICOMED ORTHO GMBH 510(k) NO: K021275(TRADITIONAL)
ATTN: CORRINE M TAFLINGER PHONE NO : 949-859-1013
22086 ELSBERRY WAY SE DECISION MADE: 18-JUL-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEM (MCS)
MICROVENTION, INC. 510(k) NO: K020434(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
72 ARGONAUT SE DECISION MADE: 29-JUL-02
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEMS (MCS)
MICROVENTION, INC. 510(k) NO: K021914(SPECIAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
72 ARGONAUT SE DECISION MADE: 09-JUL-02
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
MILLAR INSTRUMENTS, INC. 510(k) NO: K013205(TRADITIONAL)
ATTN: MONICA R MONTANEZ PHONE NO : 713-923-9171
6001-A GULF FREEWAY SE DECISION MADE: 02-JUL-02
HOUSTON, TX 77023-5417 510(k) STATEMENT
DEVICE: LIGHT SABER SPINAL NEEDLE
MINRAD, INC. 510(k) NO: K021084(TRADITIONAL)
ATTN: KIM S DEVITO PHONE NO : 716-855-1068
847 MAIN ST SE DECISION MADE: 03-JUL-02
BUFFALO, NY 14203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATING MATERIAL, BUFFERS, STANDARD
MISSION DIAGNOSTICS 510(k) NO: K022027(TRADITIONAL)
ATTN: LINDA STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 22-JUL-02
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFASTIN RC THREADED SUTURE ANCHOR
MITEK WORLDWIDE 510(k) NO: K021883(SPECIAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT AVENUE SE DECISION MADE: 01-JUL-02
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING
MOTION CONCEPTS 510(k) NO: K021264(TRADITIONAL)
ATTN: DAVID CIOLFE PHONE NO : 905 695 0134
84 CITATION DRIVE SE DECISION MADE: 30-JUL-02
CONCORD, ONTARIO, CANADA L4K 3C1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROLOY SOLDER
NEIRYNCK & VOGT NV 510(k) NO: K021965(TRADITIONAL)
ATTN: JOSH ANDRACHEK PHONE NO : 614-577-1945
12960 STONECREEK DRIVE SE DECISION MADE: 26-JUL-02
PICKERINGTON, OH 43147 510(k) STATEMENT
DEVICE: CERALOY SOLDER
NEIRYNCK & VOGT NV 510(k) NO: K021968(TRADITIONAL)
ATTN: JOSH ANDRACHEK PHONE NO : 614-577-1945
12960 STONECREEK DRIVE SE DECISION MADE: 26-JUL-02
PICKERINGTON, OH 43147 510(k) STATEMENT
DEVICE: CHROLOY
NEIRYNCK & VOGT NV 510(k) NO: K021969(TRADITIONAL)
ATTN: JOSH ANDRACHEK PHONE NO : 614-577-1945
12960 STONECREEK DRIVE SE DECISION MADE: 30-JUL-02
PICKERINGTON, OH 43147 510(k) STATEMENT
DEVICE: MODIFICATION TO EN-BLOC BIOPSY SYSTEM
NEOTHERMIA CORP. 510(k) NO: K022296(SPECIAL)
ATTN: CHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SE DECISION MADE: 30-JUL-02
SUITE 316 510(k) SUMMARY AVAILABLE FROM FDA
NATICK, MA 01760
DEVICE: NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL P
NEURON THERAPEUTICS, INC. 510(k) NO: K021196(TRADITIONAL)
ATTN: JUDY P WAYS PHONE NO : 610-578-9494
81 GREAT VALLEY PARKWAY SE DECISION MADE: 01-JUL-02
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIGAS UNIT, MODEL AG-920RA
NIHON KOHDEN AMERICA, INC. 510(k) NO: K020046(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 25-JUL-02
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSG INPUT BOX, MODEL JE-912AK
NIHON KOHDEN AMERICA, INC. 510(k) NO: K022121(SPECIAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 29-JUL-02
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE PHOX PLUS C ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K021713(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 25-JUL-02
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
NOVABONE PRODUCTS, LLC 510(k) NO: K021336(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
ONE PROGRESS BLVD. SE DECISION MADE: 25-JUL-02
SUITE 33 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615
DEVICE: OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFAN
OEMEDIC INTERNATIONAL, INC. 510(k) NO: K021442(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 30-JUL-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
OHIO MEDICAL INSTRUMENT CO., INC. 510(k) NO: K021604(TRADITIONAL)
ATTN: CHARLES E DINKLER II PHONE NO : 513-561-2241
4900 CHARLEMAR DR. SE DECISION MADE: 29-JUL-02
CINCINNATI, OH 45227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K021179(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 05-JUL-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSORB
ON SITE GAS SYSTEMS, INC. 510(k) NO: K021581(TRADITIONAL)
ATTN: FRANCIS X HURSEY PHONE NO : 860-667-8888
35 BUDNEY ROAD SE DECISION MADE: 12-JUL-02
NEWINGTON, CT 06111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM ANCHOR & INSTRUMENT SET
OPUS MEDICAL, INC. 510(k) NO: K020172(ABBREVIATED)
ATTN: JIM HART PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 22-JUL-02
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARLIGHT
ORTHOMERICA PRODUCTS, INC. 510(k) NO: K021207(TRADITIONAL)
ATTN: DEANNA FISH PHONE NO : 800-446-6770
6333 NORTH ORANGE BLOSSOM SE DECISION MADE: 09-JUL-02
TRAIL 510(k) SUMMARY AVAILABLE FROM FDA
ORLANDO, FL 32810
DEVICE: CLARREN HELMET (ORTHOMERICA)
ORTHOMERICA PRODUCTS, INC. 510(k) NO: K021918(TRADITIONAL)
ATTN: DEANNA FISH PHONE NO : 801-265-1801
6333 NORTH ORANGE BLOSSOM SE DECISION MADE: 25-JUL-02
TRAIL 510(k) SUMMARY AVAILABLE FROM FDA
ORLANDO, FL 32810
DEVICE: SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM,
ORTHOTEC,LLC 510(k) NO: K021919(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 03-JUL-02
CHESTERLAND, OH 44026-2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O&P; CRANICAL MOLDING HELMET
ORTHOTIC & PROSTHETIC LAB, INC. 510(k) NO: K021221(TRADITIONAL)
ATTN: THOMAS MALONE PHONE NO : 314-968-8555
748 MARSHALL AVE. SE DECISION MADE: 01-JUL-02
WEBSTER GROVES, MO 63119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R120 MODULAR TOTAL HIP SYSTEM
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K021822(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 23-JUL-02
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
PAN PROBE BIOTECH, INC. 510(k) NO: K020968(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 15-JUL-02
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PANAG
PANAG INTERNATIONAL 510(k) NO: K011891(TRADITIONAL)
ATTN: PETER KALABAKAS PHONE NO : 271 161 45588
43 DERBY ROAD BERTRAMS SE DECISION MADE: 30-JUL-02
JOHANNESBURG, SOUTH AFRICA 2094 510(k) STATEMENT
DEVICE: CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
PARALLAX MEDICAL, INC. 510(k) NO: K022169(SPECIAL)
ATTN: RICHARD M RUEDY PHONE NO : 831-439-0130
940 DISC DR. SE DECISION MADE: 25-JUL-02
SCOTTS VALLEY, CA 95066-4544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI ONETIME DENTAL IMPLANT
PAXMED INTERNATIONAL 510(k) NO: K022038(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 15-JUL-02
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASI 12 LEAD ALGORITHM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K020456(SPECIAL)
ATTN: PAUL SCHRADER PHONE NO : 978-659-2404
1201B NORTH RICE AVENUE SE DECISION MADE: 09-JUL-02
OXNARD, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
PHILIPS MEDICAL SYSTEMS 510(k) NO: K021453(TRADITIONAL)
ATTN: RICHARD J PETERSEN PHONE NO : 978-659-2213
3000 MINUTEMAN RD. SE DECISION MADE: 03-JUL-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
PHILIPS MEDICAL SYSTEMS 510(k) NO: K021778(TRADITIONAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 17-JUL-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS; 21315 DIAGNO
PHILIPS ULTRASOUND, INC. 510(k) NO: K022303(TRADITIONAL)
ATTN: PAUL SMOLENSKI PHONE NO : 978-659-3380
3000 MINUTEMAN ROAD SE DECISION MADE: 30-JUL-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PHFW-10
PIHSIANG MACHINERY MFG. CO. LTD. 510(k) NO: K021592(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 316-325-2629
1101 ILLINOIS SE DECISION MADE: 15-JUL-02
P.O. BOX 187 510(k) STATEMENT
NEODESHA, KS 66757
DEVICE: MPF ACETABULAR CUP GENERATION 2
PLUS ORTHOPEDICS 510(k) NO: K022120(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 24-JUL-02
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY-CHEM GLUCOSE
POLYMEDCO, INC. 510(k) NO: K020852(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
510 FURNACE DOCK RD. SE DECISION MADE: 03-JUL-02
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: MPOWER, MODEL 712 SERIES
POSITRON CORP. 510(k) NO: K022001(SPECIAL)
ATTN: IRENE C ALBRIGHT PHONE NO : 800-766-2984
1304 LANGHAM CREEK DR., #300 SE DECISION MADE: 12-JUL-02
HOUSTON, TX 77084 510(k) STATEMENT
DEVICE: LIGHT CURE DENTAL DAM
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K021524(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 19-JUL-02
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004
PRIZM MEDICAL, INC. 510(k) NO: K012974(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 23-JUL-02
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT FEEDING TUBES
PROMEDIC, INC. 510(k) NO: K020005(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 16-JUL-02
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
RADIOTHERAPEUTICS CORP. 510(k) NO: K011220(TRADITIONAL)
ATTN: GARY CURTIS PHONE NO : 408-745-3200
1308 BORREGAS AVE.SUITE 200 SE DECISION MADE: 01-JUL-02
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSET SPIRIT CPAP SYSTEM
RESMED CORP. 510(k) NO: K013843(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2282
14040 DANIELSON ST. SE DECISION MADE: 16-JUL-02
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S7 ELITE CP AP SYSTEM
RESMED CORP. 510(k) NO: K013909(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2282
14040 DANIELSON ST. SE DECISION MADE: 08-JUL-02
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
RHIGENE, INC. 510(k) NO: K022018(SPECIAL)
ATTN: YUSUKE KOBE PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 05-JUL-02
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: ROCHE ONLINE GENTAMICIN
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020704(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 12-JUL-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE DAT II METHADONE II
ROCHE DIAGNOSTICS CORP. 510(k) NO: K021505(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE ROAD SE DECISION MADE: 16-JUL-02
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: COBAS INTEGRA ONLINE DAT II METHADONE II
ROCHE DIAGNOSTICS CORP. 510(k) NO: K021512(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7627
9115 HAGUE RD. SE DECISION MADE: 16-JUL-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K021827(SPECIAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 03-JUL-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK COMPACT SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K022171(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 23-JUL-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABP FOR WINDOWS
ROZINN ELECTRONICS, INC. 510(k) NO: K021517(TRADITIONAL)
ATTN: MARK ROSOFF PHONE NO : 718-386-5526
71-22 MYRTLE AVE. SE DECISION MADE: 24-JUL-02
GLENDALE, NY 11385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH FLONEIL; FLOCATH INTROGEL
RUSCH INTL. 510(k) NO: K020714(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 01-JUL-02
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
RUSCH INTL. 510(k) NO: K021764(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
TALL PINES PARK SE DECISION MADE: 23-JUL-02
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSIR SYSTEM
RUSSIAN-AMERICAN TECHNOLOGY ASSOCI510(k) NO: K014208(TRADITIONAL)
ATTN: JOYCE HEINRICH PHONE NO : 713-777-5477
8303 S.W. FREEWAY, STE 835 SE DECISION MADE: 02-JUL-02
HOUSTON, TX 77074-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/
SEBIA 510(k) NO: K022053(SPECIAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WATERLOO SE DECISION MADE: 12-JUL-02
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: SELICOR, MODELS A100 & D100
SELICOR, INC. 510(k) NO: K020227(TRADITIONAL)
ATTN: JAMES B BINGHAM PHONE NO : 210-826-8515
515 EXTER #F7 SE DECISION MADE: 30-JUL-02
SAN ANTONIO, TX 78209 510(k) STATEMENT
DEVICE: HI-OX
SENSORMEDICS CORP. 510(k) NO: K020665(TRADITIONAL)
ATTN: EARL W DRAPER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 30-JUL-02
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER
SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K022087(TRADITIONAL)
ATTN: PETER WANG PHONE NO : 011 86 2157818521
268 YUSHU RD., CANGQIAO SE DECISION MADE: 11-JUL-02
TOWNSHIP, SONGJIANG COUNTY 510(k) STATEMENT
SHANGHAI, CHINA 201600
DEVICE: INFINITY MICRO2+
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K012770(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 23-JUL-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNGCARE CT SOFTWARE PACKAGE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022013(TRADITIONAL)
ATTN: PRAVEEN P NADKARNI PHONE NO : 732-321-4950
186 WOOD AVENUE SOUTH SE DECISION MADE: 16-JUL-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GREAT TOE IMPLANT
SIGNAL MEDICAL CORP. 510(k) NO: K021063(TRADITIONAL)
ATTN: LOUIS A SERAFIN PHONE NO : 810-966-3917
3777 LAPEER RD. 3-C SE DECISION MADE: 01-JUL-02
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQ NASAL MASK, MODEL 50160 REV. D
SLEEPNET CORP. 510(k) NO: K021534(SPECIAL)
ATTN: PAUL R CHIESA PHONE NO : 603-624-1911
1050 PERIMETER RD., SE DECISION MADE: 02-JUL-02
LOCKHEED AIR CENTER 510(k) STATEMENT
MANCHESTER, NH 03103
DEVICE: STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM
SMART GLOVE CORP. SDN BHD 510(k) NO: K021521(TRADITIONAL)
ATTN: NG YEW SOON PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 02-JUL-02
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: AMC ANTIMICROBIAL PIN/WIRE SLEEVE
SMITH & NEPHEW, INC. 510(k) NO: K012193(TRADITIONAL)
ATTN: JEFF F DOERZBACHER PHONE NO : 901-399-5224
1450 E. BROOKS ROAD SE DECISION MADE: 11-JUL-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAQUIET
SOUND TECHNIQUE SYSTEM, LLC 510(k) NO: K021202(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTTEENTH STREET N.W. SE DECISION MADE: 13-JUL-02
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEP
SPIRE BIOMEDICAL INC 510(k) NO: K022000(SPECIAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 19-JUL-02
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEAMPLUS STERILIZATION TEST
SPS MEDICAL SUPPLY CORP. 510(k) NO: K020409(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 18-JUL-02
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
STELKAST COMPANY 510(k) NO: K021908(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY ROAD SE DECISION MADE: 09-JUL-02
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: PRISMAFLO
STIHLER ELECTRONIC GMBH 510(k) NO: K020103(ABBREVIATED)
ATTN: RICHARD C LANZILLOTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 24-JUL-02
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: RE-ENTRANT CHAMBER
SUN NUCLEAR CORP. 510(k) NO: K013689(TRADITIONAL)
ATTN: JIM MIXON PHONE NO : 321-269-6262
425-A PINEDA COURT SE DECISION MADE: 02-JUL-02
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS SLEEP RECORDER MODEL # RM60
SUNRISE MEDICAL HHG, INC. 510(k) NO: K012437(TRADITIONAL)
ATTN: JIM FROEHLICH PHONE NO : 814-443-7690
100 DEVILBISS DR. SE DECISION MADE: 16-JUL-02
SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED TROCARS AND CANNULAS
SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K012644(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E COLUMBINE DRIVE SE DECISION MADE: 29-JUL-02
PHOENIX, AZ 85032-5655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
SURGICAL SPECIALTIES CORP. 510(k) NO: K020882(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DRIVE SE DECISION MADE: 26-JUL-02
READING, PA 19606-3776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC TIPS WITH DIAMOND COATING
SYBRON ENDO/ANALYTIC 510(k) NO: K021253(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 05-JUL-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
SYNCRO MEDICAL INNOVATIONS, INC. 510(k) NO: K021991(SPECIAL)
ATTN: SABRY A GABRIEL PHONE NO : 478-301-4093
433 CHERRY STREET, LL#6 SE DECISION MADE: 18-JUL-02
MACON, GA 31201-7950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA DS
SYNERON MEDICAL LTD. 510(k) NO: K021149(TRADITIONAL)
ATTN: AMIR WALDMANN PHONE NO : 972 490 97424
POB 550 SE DECISION MADE: 09-JUL-02
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEBRAL SPACER
SYNTHES (USA) 510(k) NO: K011037(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 01-JUL-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORBABLE CRANIAL CLAMPS
SYNTHES (USA) 510(k) NO: K021408(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 29-JUL-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES IN-SITU BENDER/CUTTER
SYNTHES (USA) 510(k) NO: K021458(ABBREVIATED)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 24-JUL-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
SYNTHES (USA) 510(k) NO: K022255(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 25-JUL-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTOUCH MASSAGE THERAPY SYSTEM
TACTILE SYSTEMS TECHNOLOGY INC 510(k) NO: K013061(TRADITIONAL)
ATTN: ERIC MCKEE PHONE NO : 763-434-2888
1074 LEGION STREET SE DECISION MADE: 01-JUL-02
SHAKOPEE, MN 55379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAGG DISPOSABLE VAGINAL SPECULUM
TAGG INDUSTRIES 510(k) NO: K021849(TRADITIONAL)
ATTN: TERRY L SHIRLEY PHONE NO : 949-770-9029
23210 DEL LAGO SE DECISION MADE: 16-JUL-02
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: NERVUS MONITOR
TAUGAGREINING HF 510(k) NO: K021185(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
PO BOX 4341 SE DECISION MADE: 12-JUL-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
THE BINDING SITE, LTD. 510(k) NO: K022083(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 16-JUL-02
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PR
THE ELECTRIC STORE 510(k) NO: K020910(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 206-720-1540
936-11TH AVENUE EAST SE DECISION MADE: 19-JUL-02
SEATTLE, WA 98102 510(k) STATEMENT
DEVICE: THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
THERALIGHT, INC. 510(k) NO: K022165(TRADITIONAL)
ATTN: RAYMOND HARTMAN PHONE NO : 760-930-8000
2794 LOKER AVE. WEST,SUITE 105 SE DECISION MADE: 18-JUL-02
CARLSBAD, CA 92008-6616 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWERED MUSCLE STIMULATOR
THERATECH, INC. 510(k) NO: K013768(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 03-JUL-02
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TTECH MODEL 200E + TENS DEVICE
THERATECH, INC. 510(k) NO: K021436(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 30-JUL-02
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
THERMO DMA, INC. 510(k) NO: K022108(TRADITIONAL)
ATTN: THOMAS DOLLAR PHONE NO : 817-607-1717
845 AVE. G EAST SE DECISION MADE: 25-JUL-02
ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMI
TILLOTSON HEALTHCARE CORP. 510(k) NO: K021007(TRADITIONAL)
ATTN: FRANK W PERRELLA PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 05-JUL-02
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSTWO MODEL TME-601 ROOT APEX LOCATOR
TOEI ELECTRIC CO., LTD. 510(k) NO: K022020(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 02-JUL-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HLS NOETOS SYSTEM
TORNIER S.A. 510(k) NO: K013906(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 17-JUL-02
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K022050(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 09-JUL-02
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
TUTTNAUER USA CO. LTD. 510(k) NO: K021504(ABBREVIATED)
ATTN: TODD H HALPERN PHONE NO : 202-452-7963
1776 K STREET, N.W. SE DECISION MADE: 25-JUL-02
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-7910
DEVICE: MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
UNITED STATES SURGICAL 510(k) NO: K021825(SPECIAL)
ATTN: TINA RIDEOUT PHONE NO : 203-845-4520
150 GLOVER AVE. SE DECISION MADE: 01-JUL-02
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
USA INSTRUMENTS, INC. 510(k) NO: K021330(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 25-JUL-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012688(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 31-JUL-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
VECTOR MEDICAL, INC. 510(k) NO: K022225(SPECIAL)
ATTN: ERIN MCGURK PHONE NO : 650-327-7719
1886 LODGEPOLE DRIVE SE DECISION MADE: 25-JUL-02
MILTON, FL 32583 510(k) STATEMENT
DEVICE: VISION SCIENCES ENDOSHEATH SYSTEM
VISION-SCIENCES, INC. 510(k) NO: K012543(TRADITIONAL)
ATTN: PAMELA PAPINEU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 15-JUL-02
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1
VITAL SCIENTIFIC N.V. 510(k) NO: K022046(TRADITIONAL)
ATTN: ISRAEL M STEIN PHONE NO : 617-527-9933
ONE GATEWAY CENTER SUITE 411 SE DECISION MADE: 23-JUL-02
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADMIRA SEAL
VOCO GMBH 510(k) NO: K021842(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 514-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 29-JUL-02
BEND, OR 97702 510(k) STATEMENT
DEVICE: ADMIRA PROTECT
VOCO GMBH 510(k) NO: K021844(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 19-JUL-02
BEND, OR 97702 510(k) STATEMENT
DEVICE: WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
W.A. RUBBERMATE CO., LTD. 510(k) NO: K021041(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-682-0224
22411 60TH STREET SE DECISION MADE: 30-JUL-02
BRISTOL, WI 53104 510(k) STATEMENT
DEVICE: ENDOCERVICAL BLOCK NEEDLE
WALLACH SURGICAL DEVICES, INC. 510(k) NO: K021224(TRADITIONAL)
ATTN: MICHAEL MALIS PHONE NO : 203-799-2000
235 EDISON RD. SE DECISION MADE: 12-JUL-02
ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPAQ, MODELS 402, 404
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K021681(SPECIAL)
ATTN: DON M ABBEY PHONE NO : 503-530-7500
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 23-JUL-02
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
WFR/AQUAPLAST CORP. 510(k) NO: K021124(TRADITIONAL)
ATTN: J DAMON KIRK PHONE NO : 201-891-1042
30 LAWLINS PARK SE DECISION MADE: 02-JUL-02
WYCKOFF, NJ 07481 510(k) STATEMENT
DEVICE: AUROPAL 60
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K021926(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 072 313705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 25-JUL-02
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER
WIENER LABORATORIES S.A.I.C. 510(k) NO: K021332(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 03-JUL-02
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
WILSON-COOK MEDICAL, INC. 510(k) NO: K011591(TRADITIONAL)
ATTN: PAULA JOYCE PHONE NO : 910-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 19-JUL-02
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: READI-STRAND; MODEL PSSTRAND
WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K020337(TRADITIONAL)
ATTN: GARY LAMOUREUX PHONE NO : 203-263-2579
426 MAIN ST. NORTH SE DECISION MADE: 29-JUL-02
P.O. BOX 505 510(k) STATEMENT
WOODBURY, CT 06798-0505
DEVICE: STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K021346(ABBREVIATED)
ATTN: ROGER D BROWN PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 02-JUL-02
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K021349(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 01-JUL-02
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DA
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K021119(TRADITIONAL)
ATTN: KK LEONG PHONE NO : 603 870 61486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 05-JUL-02
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE L
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K021159(TRADITIONAL)
ATTN: K. K LEONG PHONE NO : 603 870 61486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 03-JUL-02
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES,
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K021784(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 870 61486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 24-JUL-02
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR, MALAYSIA 43900
DEVICE: WU'S 4-WHEELED NEO SCOOTER, WT-L4
WU'S TECH CO., LTD. 510(k) NO: K013763(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 30-JUL-02
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) STATEMENT
DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-M3
WU'S TECH CO., LTD. 510(k) NO: K014119(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-JUL-02
NSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: QIZHOU ACUPUNCTURE NEEDLE
WUJIANG CITY SHENLI MEDICAL & HEAL510(k) NO: K013926(TRADITIONAL)
ATTN: GONG BO PHONE NO : 008 602 164957283
503 ROOM, 8 BUILDING, SE DECISION MADE: 18-JUL-02
600 LIU ZHON ROAD 510(k) STATEMENT
SHANGHI, CHINA 200233
DEVICE: XTD THROMBECTOMY CATHETER, XX CM
XTRAK MEDICAL INC. 510(k) NO: K021641(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY TRAIL SE DECISION MADE: 26-JUL-02
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
ZETA DEVELOPMENT LABORATORIES 510(k) NO: K022164(TRADITIONAL)
ATTN: MARK T FUKUHARA PHONE NO : 916-941-0800
4990 HILLSIDE CIRCLE SE DECISION MADE: 26-JUL-02
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
EL DORADO HILLS, CA 95762 THIRD PARTY REVIEW
DEVICE: EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
ZIMMER, INC. 510(k) NO: K014070(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 219-372-4219
P.O. BOX 708 SE DECISION MADE: 30-JUL-02
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 326
TOTAL WITH SUMMARIES 257
TOTAL WITH STATEMENTS 69
Updated 08/05/2002
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