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510(k)s Final Decisions Rendered for February 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-FEB-2002 THROUGH 28-FEB-2002
DEVICE: UNITE BONDING ADHESIVE
3M UNITEK 510(k) NO: K014142(TRADITIONAL)
ATTN: L. MARLYN SCHEFF PHONE NO : 626-574-4496
2724 SOUTH PECK RD. SE DECISION MADE: 28-FEB-02
MONROVIA, CA 91016 510(k) STATEMENT
DEVICE: A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOO
A & D ENGINEERING, INC. 510(k) NO: K012472(TRADITIONAL)
ATTN: JERRY WANG PHONE NO : 408-263-5333
1555 MCCANDLESS DR. SE DECISION MADE: 15-FEB-02
MILPITAS, CA 95035 510(k) STATEMENT
DEVICE: AARON REUSABLE ELECTROSURGICAL ELECTRODE
AARON MEDICAL INDUSTRIES 510(k) NO: K014201(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 25-FEB-02
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST
ABBOTT LABORATORIES 510(k) NO: K012975(TRADITIONAL)
ATTN: JANET S CONNOLLY PHONE NO : 781-276-6230
4-A CROSBY DR. SE DECISION MADE: 28-FEB-02
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX MICROS 60 HEMATOLOGY ANALYZER
ABX DIAGNOSTICS 510(k) NO: K014203(TRADITIONAL)
ATTN: TOM M PHILLIPS PHONE NO : 949-453-0500
34 BUNSEN DR. SE DECISION MADE: 28-FEB-02
IRVINE, CA 92618-4210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
ACULUX, , INC. 510(k) NO: K013511(TRADITIONAL)
ATTN: KIM MARSH PHONE NO : 941-643-8023
273 SOUTH AIRPORT PULLING RD. SE DECISION MADE: 01-FEB-02
NAPLES, FL 34104 510(k) STATEMENT
DEVICE: AOS CANNULATED BONE SCREW SYSTEM
ADVANCED ORTHOPAEDIC SOLUTIONS 510(k) NO: K014185(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 310-831-4433
333 WEST 6TH ST., SUITE 202 SE DECISION MADE: 13-FEB-02
SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD CYCLESURE BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K994055(TRADITIONAL)
ATTN: KEVIN CORRIGAN PHONE NO : 949-453-6410
33 TECHNOLOGY DR. SE DECISION MADE: 13-FEB-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEACE OF MIND HOME DRUG TEST
ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K013778(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 650-569-3852
1201 DOUGLAS AVE. SE DECISION MADE: 07-FEB-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
ADVEN MEDICAL 510(k) NO: K012675(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 12-FEB-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
ADVEN MEDICAL 510(k) NO: K012676(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 04-FEB-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
ADVEN MEDICAL 510(k) NO: K012694(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 04-FEB-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
ADVEN MEDICAL 510(k) NO: K012696(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 04-FEB-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
AFP IMAGING CORP. 510(k) NO: K014144(TRADITIONAL)
ATTN: DAVID VOZICK PHONE NO : 914-592-6100
250 CLEARBROOK RD. SE DECISION MADE: 07-FEB-02
ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
AFX, INC. 510(k) NO: K013946(TRADITIONAL)
ATTN: NANCY NORRIS PHONE NO : 510-651-7430
47929 FREMONT BOULEVARD SE DECISION MADE: 27-FEB-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANX
AIR TECHNIQUES, INC. 510(k) NO: K013893(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 01-FEB-02
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION
ALLERGAN, INC. 510(k) NO: K013479(TRADITIONAL)
ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761
2525 DUPONT DRIVE SE DECISION MADE: 11-FEB-02
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION
ALLERGAN, INC. 510(k) NO: K014202(TRADITIONAL)
ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761
2525 DUPONT DRIVE SE DECISION MADE: 20-FEB-02
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED HOT BIOPSY FORCEPS
ALLIANCE MEDICAL CORP. 510(k) NO: K012607(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 04-FEB-02
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED AUTOSUTURE LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
ALLIANCE MEDICAL CORP. 510(k) NO: K012608(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST. STREET SE DECISION MADE: 14-FEB-02
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED POLYPECTOMY SNARES
ALLIANCE MEDICAL, INC. 510(k) NO: K012610(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51 STREET SE DECISION MADE: 19-FEB-02
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
APPLE MEDICAL CORP. 510(k) NO: K014005(TRADITIONAL)
ATTN: JOHN C PULFORD PHONE NO : 508-357-2700
28 LORD RD., UNIT 135 SE DECISION MADE: 15-FEB-02
MARLBORO, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K014047(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8000
22872 AVENIDA EMPRESSA SE DECISION MADE: 28-FEB-02
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN CRYSTAL CLEAR LIQUID
ARMKEL LLC 510(k) NO: K013614(TRADITIONAL)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-655-6308
P.O. BOX 1001 HALF ACRE RD SE DECISION MADE: 01-FEB-02
CRANBURY,, NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASER SYSTEM YELLOWSTAR
ASCLEPION-MEDITEC AG 510(k) NO: K013940(TRADITIONAL)
ATTN: WILLIAM KELLEY PHONE NO :
2961 W. MAC ARTHUR BLVD. #133 SE DECISION MADE: 26-FEB-02
SANTA ANA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE LIGHT HANDLE AND ADAPTOR
ASPEN SURGICAL PRODUCTS, INC. 510(k) NO: K020304(TRADITIONAL)
ATTN: ROY MELLING PHONE NO : 888-364-7004
7425 CLYDE PARK, SUITE G SE DECISION MADE: 14-FEB-02
GRAND RAPIDS, MI 49315-0404 510(k) STATEMENT
DEVICE: SI ASCOPE
ASTRON CLINICA LIMITED 510(k) NO: K011273(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 20-FEB-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: SPHYGMOCOR PX MODEL SCOR-PX
ATCOR MEDICAL PTY. LTD 510(k) NO: K012487(TRADITIONAL)
ATTN: KIRSTEN PAULSON PHONE NO : 301-933-1914
1400 16TH STREET, NW SE DECISION MADE: 21-FEB-02
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
ATOS MEDICAL AB 510(k) NO: K014102(SPECIAL)
ATTN: EDDY ABERG PHONE NO : 464 151 9800
KRAFTGATAN 8 SE DECISION MADE: 21-FEB-02
HORBY, SWEDEN SE-242 22 510(k) STATEMENT
DEVICE: TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION
BACCHUS VASCULAR, INC. 510(k) NO: K013635(TRADITIONAL)
ATTN: GREG MATHISON PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 11-FEB-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-3
BARNSTEAD/THERMOLYNE CORP. 510(k) NO: K014174(TRADITIONAL)
ATTN: MIA M WARE PHONE NO : 563-556-2241
P.O. BOX 797 SE DECISION MADE: 22-FEB-02
DUBUQUE, IA 52001 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K012357(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 28-FEB-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AN
BAYLIS MEDICAL CO., INC. 510(k) NO: K013904(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DRIVE, UNIT 33 SE DECISION MADE: 12-FEB-02
MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT
DEVICE: TORFLEX TRANSSEPTAL GUIDING SHEATH
BAYLIS MEDICAL CO., INC. 510(k) NO: K013919(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DRIVE, UNIT 33 SE DECISION MADE: 22-FEB-02
MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT
DEVICE: BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
BCI, INC. 510(k) NO: K013862(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 21-FEB-02
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BECKER BAND CRANIAL REMOLDING ORTHOSIS
BECKER ORTHOPEDIC APPLIANCE CO. 510(k) NO: K013719(TRADITIONAL)
ATTN: JAMES H CAMPBELL PHONE NO : 248-588-6961
635 EXECUTIVE DR. SE DECISION MADE: 05-FEB-02
TROY, MI 48083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
BECKMAN COULTER, INC. 510(k) NO: K014173(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 15-FEB-02
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER SAFETY COAGULATION TUBE
BECTON DICKINSON & CO. 510(k) NO: K013971(TRADITIONAL)
ATTN: KEITH SMITH PHONE NO : 201-847-5837
1 BECTON DRIVE SE DECISION MADE: 01-FEB-02
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BERCHTOLD ELEKTROTOM 106 HITT
BERCHTOLD CORP. 510(k) NO: K013668(TRADITIONAL)
ATTN: MARIKA ANDERSON PHONE NO : 626-398-8934
590 CROSBY ST. SE DECISION MADE: 04-FEB-02
ALTADENA, CA 91001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
BIOGENEX LABORATORIES 510(k) NO: K013148(TRADITIONAL)
ATTN: GURVINDER S NANDA PHONE NO : 925-543-1336
4600 NORRIS CANYON RD. SE DECISION MADE: 28-FEB-02
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATERLASE MILLENNIUM
BIOLASE TECHNOLOGY, INC. 510(k) NO: K013908(TRADITIONAL)
ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200
981 CALLE AMANECER SE DECISION MADE: 12-FEB-02
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013923(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 25-FEB-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPICCI II UNICONDYLAR KNEE SYSTEM
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020264(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 08-FEB-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSORBFX O/M 2.0/2/4 SYSTEM
BIONX IMPLANTS, INC. 510(k) NO: K011569(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65679
HERMIANKATU 6-8 L SE DECISION MADE: 22-FEB-02
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
BIOPLATE, INC. 510(k) NO: K020088(SPECIAL)
ATTN: CAROL E JONES PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 08-FEB-02
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWGUARD DEVICE
BIOSONIX LTD. 510(k) NO: K013803(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 13-FEB-02
20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: E-SCAN XQ
BIOSOUND ESAOTE, INC. 510(k) NO: K020164(SPECIAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 12-FEB-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
BLACKSTONE MEDICAL, INC. 510(k) NO: K013885(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 01-FEB-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
BOB J. JOHNSON & ASSOC., INC 510(k) NO: K014169(TRADITIONAL)
ATTN: ROBERT SNYDER PHONE NO : 210-684-7638
7715 MAINLAND DR. # 115 SE DECISION MADE: 06-FEB-02
SAN ANTONIO,, TX 78250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
BOEHRINGER LABORATORIES 510(k) NO: K014187(TRADITIONAL)
ATTN: JOHN KARPOWICZ PHONE NO : 610-278-0900
500 E. WASHINGTON STREET SE DECISION MADE: 06-FEB-02
NORRISTOWN, PA 19401 510(k) STATEMENT
DEVICE: BACK-UP MEIER STEERABLE GUIDEWIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K020283(TRADITIONAL)
ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 11-FEB-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K013717(TRADITIONAL)
ATTN: RUOMEI ZHANG PHONE NO : 310-530-5955
3300 FUJITA STREET SE DECISION MADE: 06-FEB-02
TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
CANDELA CORP. 510(k) NO: K013748(TRADITIONAL)
ATTN: L NELSON PHONE NO : 508-358-7637
530 BOSTON POST ROAD SE DECISION MADE: 11-FEB-02
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM
CANDELA CORP. 510(k) NO: K013825(TRADITIONAL)
ATTN: LORRAINE NELSON PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 15-FEB-02
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TM2000, MODEL 1
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K013879(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484600
2 PEKERIS STREET SE DECISION MADE: 01-FEB-02
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODE
CARDIONET, INC 510(k) NO: K012241(TRADITIONAL)
ATTN: DONALD V CANAL PHONE NO : 619-243-7500
510 MARKET STREET SE DECISION MADE: 01-FEB-02
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
CARDIOPULMONARY CORP. 510(k) NO: K020018(TRADITIONAL)
ATTN: JOHN LAVIOLA PHONE NO : 203-301-6212
200 CASCADE BLVD. SE DECISION MADE: 21-FEB-02
MILFORD, CT 06460 510(k) STATEMENT
DEVICE: CARESIDE APTT
CARESIDE HEMOTOLOGY, INC. 510(k) NO: K014028(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 08-FEB-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAVITAT ULTRASOUND BONE DENSITOMETER ("CAVITAT")
CAVITAT MEDICAL TECHNOLOGIES, INC.510(k) NO: K011147(TRADITIONAL)
ATTN: LARRY R PILOT PHONE NO : 202-496-7500
1900 K STREET, N.W. SE DECISION MADE: 15-FEB-02
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHASE CARDIOVASCULAR PATCH KIT
CHASE MEDICAL, INC. 510(k) NO: K020132(TRADITIONAL)
ATTN: DAVE HERNON PHONE NO : 972-783-0644
1710 FIRMAN DRIVE SE DECISION MADE: 26-FEB-02
SUITE 100 510(k) STATEMENT
RICHARDSON, TX 75081
DEVICE: EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
CHAY MEDICAL, LLC. 510(k) NO: K013342(TRADITIONAL)
ATTN: STEPHEN C PEARSON PHONE NO : 707-481-3204
3257 ROUTE 128 SE DECISION MADE: 15-FEB-02
CALISTOGA, CA 94515 510(k) STATEMENT
DEVICE: OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (H
CL MCINTOSH 510(k) NO: K020193(ABBREVIATED)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PKWY. STE. 230 SE DECISION MADE: 28-FEB-02
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL
CLEAR MEDICAL, INC. 510(k) NO: K012601(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 06-FEB-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL
CLEAR MEDICAL, INC. 510(k) NO: K012606(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 06-FEB-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZ
CLEAR MEDICAL, INC. 510(k) NO: K012612(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 06-FEB-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE),
CLEAR MEDICAL, INC. 510(k) NO: K012616(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 06-FEB-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
CLEAR MEDICAL, INC. 510(k) NO: K012621(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 06-FEB-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTAL MONITOR MODEL 16
CLEVELAND MEDICAL DEVICES, INC. 510(k) NO: K013863(TRADITIONAL)
ATTN: ROBERT N SCHMIDT PHONE NO : 216-791-6720
11000 CEDAR AVE., SUITE 130 SE DECISION MADE: 19-FEB-02
CLEVELAND, OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
CLINICON CORP. 510(k) NO: K014048(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 11-FEB-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: TASK FORCE MONITOR 3040
CNSYSTEMS MEDIZINTECHNIK GMBH 510(k) NO: K014063(TRADITIONAL)
ATTN: CHRISTIAN WAGNER PHONE NO : 43 316 7234560
BAUMKIRCHERSTRASSE 1 SE DECISION MADE: 07-FEB-02
A-8020 GRAZ 510(k) SUMMARY AVAILABLE FROM FDA
EUROPE, AUSTRIA THIRD PARTY REVIEW
DEVICE: COBE REVOLUTION
COBE CARDIOVASCULAR, INC. 510(k) NO: K011835(ABBREVIATED)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 12-FEB-02
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODENT DENTAL LASER SYSTEM
CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K013216(TRADITIONAL)
ATTN: RONALD KOHLHARDT PHONE NO : 408-727-3240
3150 CENTRAL EXPRESSWAY SE DECISION MADE: 27-FEB-02
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTE
COOK UROLOGICAL, INC. 510(k) NO: K014160(TRADITIONAL)
ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 08-FEB-02
P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA
SPENCER, IN 47460
DEVICE: ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
COOK, INC. 510(k) NO: K013241(TRADITIONAL)
ATTN: HEIDI MASTEN PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 21-FEB-02
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
COOK, INC. 510(k) NO: K013252(TRADITIONAL)
ATTN: HEIDI MASTEN PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 21-FEB-02
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K020052(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 305-824-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 11-FEB-02
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GINDA GUARD
COSMEDENT, INC. 510(k) NO: K011239(TRADITIONAL)
ATTN: MICHAEL O'MALLEY PHONE NO : 312-644-9586
401 N. MICHIGAN AVE. SE DECISION MADE: 14-FEB-02
SUITE 2500 510(k) STATEMENT
CHICAGO, IL 60611
DEVICE: CP-SLEEVE
CP MEDICAL 510(k) NO: K013975(TRADITIONAL)
ATTN: MARY ANN GREENWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 22-FEB-02
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTEPIL
CYNOSURE, INC. 510(k) NO: K020107(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 07-FEB-02
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH TETRA
DADE BEHRING, , INC. 510(k) NO: K020173(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTA
DADE BEHRING, , INC. 510(k) NO: K020185(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN
DADE BEHRING, INC. 510(k) NO: K020168(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH NETIL
DADE BEHRING, INC. 510(k) NO: K020182(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-372-1900
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH AMIKA
DADE BEHRING, INC. 510(k) NO: K020209(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH IMIPE
DADE BEHRING, INC. 510(k) NO: K020246(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH MEROP
DADE BEHRING, INC. 510(k) NO: K020249(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BOULEVARD SE DECISION MADE: 06-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFUR
DADE BEHRING, INC. 510(k) NO: K020328(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BOULEVARD SE DECISION MADE: 19-FEB-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PG
DAKO CORP. 510(k) NO: K020023(TRADITIONAL)
ATTN: GRETCHEN M MURRAY PHONE NO : 805-566-6655
6392 VIA REAL SE DECISION MADE: 28-FEB-02
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
DATASCOPE CORP. 510(k) NO: K011540(ABBREVIATED)
ATTN: SUSAN E MANDY PHONE NO : 201-995-8391
800 MACARTHUR BLVD. SE DECISION MADE: 06-FEB-02
MAHWAK, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETPOLISHER
DELDENT LTD. 510(k) NO: K014249(TRADITIONAL)
ATTN: ALAN EDEL PHONE NO : 972 3 9049668
19 KEREN KAYEMET STREET SE DECISION MADE: 19-FEB-02
PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT
DEVICE: JETSTREAM
DELDENT LTD. 510(k) NO: K014252(TRADITIONAL)
ATTN: ALAN EDEL PHONE NO : 972 3 9049668
19 KEREN KAYEMET STREET SE DECISION MADE: 19-FEB-02
PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT
DEVICE: DEPILASE TWIN LASE LASER SYSTEM
DEPILASE GROUP LTD. 510(k) NO: K020412(TRADITIONAL)
ATTN: MARIO RUSSO PHONE NO : 442 077 121675
ONE CANADA SQUARE SE DECISION MADE: 22-FEB-02
LONDON, UNITED KINGDOM E14 5DY 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DEPILASE YAG LASE PLUS LASER SYSTEM
DEPILASE GROUP LTD. 510(k) NO: K020463(TRADITIONAL)
ATTN: MARIO LUCA RUSSO PHONE NO : 44 20 77121675
ONE CANADA SQUARE SE DECISION MADE: 27-FEB-02
LONDON, UNITED KINGDOM E14 5DY 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BONART ART-E1 ELECTROSURGERY UNIT
DIAGNOSTIC DATA, INC. 510(k) NO: K020080(TRADITIONAL)
ATTN: ROBERT E JOHNSON PHONE NO : 909-946-0099
1342-D NORTH BENSON AVENUE SE DECISION MADE: 19-FEB-02
UPLAND, CA 91786 510(k) STATEMENT
DEVICE: TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
DIAGNOSTICS BIOCHEM CANADA, INC. 510(k) NO: K014120(TRADITIONAL)
ATTN: G. R. DUMONT PHONE NO : 519 681 8731
1020 HARGRIEVE RD. SE DECISION MADE: 08-FEB-02
LONDON, ONTARIO, CANADA N6E 1P5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
DIDECO S.P.A. 510(k) NO: K020351(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 26-FEB-02
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRG REACTION CHAMBER/SAFETY TIP
DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K012003(TRADITIONAL)
ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422
143 WOLCOTT RD. SE DECISION MADE: 12-FEB-02
WOLCOTT, CT 06716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
DOLPHIN MEDICAL INC. 510(k) NO: K020075(SPECIAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE SE DECISION MADE: 08-FEB-02
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
DRAEGER MEDICAL, INC. 510(k) NO: K011404(TRADITIONAL)
ATTN: MICHAIL A KELHART PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 22-FEB-02
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIN-2 TANGO ELITE NP
DURABLE MEDICAL EQUIPMENT, INC. 510(k) NO: K013361(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DR. SE DECISION MADE: 26-FEB-02
PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTOCO2L INSUFFLATOR MODEL 6400
E-Z-EM, INC. 510(k) NO: K013219(ABBREVIATED)
ATTN: ROBERT WILLIAMS PHONE NO : 516-333-8433
717 MAIN ST. SE DECISION MADE: 19-FEB-02
WESTBURY, NY 11590 510(k) STATEMENT
DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
EBI, L.P. 510(k) NO: K020141(SPECIAL)
ATTN: PATRICIA M FLOOD PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 05-FEB-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTITCH SUTURING DEVICE
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K013990(TRADITIONAL)
ATTN: LUCINDA STOCKERT PHONE NO : 949-250-2438
ONE EDWARDS WAY SE DECISION MADE: 27-FEB-02
IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHING CIRCUIT FILTER
EMERGENCY FILTRATION PRODUCTS, INC510(k) NO: K012958(TRADITIONAL)
ATTN: DOUGLAS K BEPLATE PHONE NO : 702-798-4541
4335 SOUTH INDUSTRIAL RD.,#440 SE DECISION MADE: 22-FEB-02
LAS VEGAS, NV 89103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
ENCORE ORTHOPEDICS, INC. 510(k) NO: K020170(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 11-FEB-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PASS SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K020236(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 14-FEB-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS CERVICAL PLATE SYSTEM
ENDIUS, INC. 510(k) NO: K014107(TRADITIONAL)
ATTN: GENE DIPOTO PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 13-FEB-02
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIAL ROTATION KNEE SYSTEM
ENGINEERING CONSULTING SERVICES, I510(k) NO: K020214(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 26-FEB-02
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOANCHOR AND OPENANCHOR
ETHICON ENDO-SURGERY, INC. 510(k) NO: K013749(TRADITIONAL)
ATTN: DOUG KENTZ PHONE NO : 513-337-8699
4545 CREEK RD. SE DECISION MADE: 11-FEB-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM RO
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K012463(TRADITIONAL)
ATTN: ROBERT TU PHONE NO : 886 226 620038
3 FL.NO.5 LN.155 BEI-SHEND RD. SE DECISION MADE: 05-FEB-02
SEC. 3 510(k) STATEMENT
SHEN KENG HSIANG,TAIPEI HSIEN, CHINA (TAIWAN) 222
DEVICE: EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
EXACTECH, INC. 510(k) NO: K020291(SPECIAL)
ATTN: ROBERT PAXTON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 27-FEB-02
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIC HEMOSTASIS REFERENCE EMULSION
FISHER DIAGNOSTICS 510(k) NO: K013397(TRADITIONAL)
ATTN: JERALD P STEINER PHONE NO : 540-869-3200
8365 VALLEY PIKE SE DECISION MADE: 15-FEB-02
P.O. BOX 307 510(k) STATEMENT
MIDDLETOWN, VA 22645-3200
DEVICE: SMARTFLOW PULSE TRANSMISSION COEFFICIENT
FLORENCE MEDICAL LTD. 510(k) NO: K020127(SPECIAL)
ATTN: ORLY MAOR PHONE NO : 972 977 18130
117 AHUZAH STREET SE DECISION MADE: 14-FEB-02
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WH
FORMOSA GLOVE INDUSTRIAL CO., LTD.510(k) NO: K014284(TRADITIONAL)
ATTN: TIANG S CHANG PHONE NO : 908-233-3571
1016 SEWARD AVE. SE DECISION MADE: 15-FEB-02
WESTFIELD, NJ 07090 510(k) STATEMENT
DEVICE: NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE
FORMOSA GLOVE INDUSTRIAL CO., LTD.510(k) NO: K014285(TRADITIONAL)
ATTN: TIANG S CHANG PHONE NO : 908-233-3571
1016 SEWARD AVE. SE DECISION MADE: 14-FEB-02
WESTFIELD, NJ 07090 510(k) STATEMENT
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-5700
FUKUDA DENSHI USA, INC. 510(k) NO: K020084(SPECIAL)
ATTN: LARRY D WALKER PHONE NO : 800-365-6668
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 06-FEB-02
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIFIL BOND
GC AMERICA, INC. 510(k) NO: K013997(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 20-FEB-02
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GC FUJI LINING LC PASTE PAK
GC AMERICA, INC. 510(k) NO: K020117(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 28-FEB-02
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SIT
GDS TECHNOLOGY 510(k) NO: K020138(SPECIAL)
ATTN: RICHARD TYHACH PHONE NO : 219-264-7384
25235 LEER DR. SE DECISION MADE: 11-FEB-02
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE WORKSTATION 4.1
GE MEDICAL SYSTEMS 510(k) NO: K020483(TRADITIONAL)
ATTN: SCOTT R EVANS PHONE NO : 847-704-8878
800 BUSINESS CENTER DR. SE DECISION MADE: 28-FEB-02
MOUNT PROSPECT, IL 60056 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K020022(SPECIAL)
ATTN: THOMAS ENGLISH PHONE NO : 817-887-2107
4502 WOODLAND CORP.BLVD. SE DECISION MADE: 01-FEB-02
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ 3
GENERAL ELECTRIC CO. 510(k) NO: K020263(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 06-FEB-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR 8000M SYSTEM
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K012467(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 11-FEB-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTLE COLONICS IRRIGATION SYSTEM
GENTLE COLONICS, INC. 510(k) NO: K002102(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO SE DECISION MADE: 06-FEB-02
IRVINE, CA 92606-1849 510(k) STATEMENT
DEVICE: SOFTIQUE, MODEL GI 11001
GLOBAL TV CONCEPTS, LTD. 510(k) NO: K013707(TRADITIONAL)
ATTN: LAURIE BRADEN PHONE NO : 954-570-9999
676 SOUTH MILITARY TRAIL SE DECISION MADE: 01-FEB-02
DEERFIELD BEACH, FL 33442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWIN PLUS
GRASS-TELEFACTOR DIVISON 510(k) NO: K012976(TRADITIONAL)
ATTN: JOHN B CHATTEN PHONE NO : 401-828-4000
SE DECISION MADE: 12-FEB-02
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE EDTA K2 TUBES
GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K014104(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 01-FEB-02
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOVIEW 5 HARVESTING CANNULA
GUIDANT CARDIAC SURGERY 510(k) NO: K020143(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842
3200 LAKESIDE DR. SE DECISION MADE: 20-FEB-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AGILTRAC .018 PERIPHERAL DILATATION CATHETER
GUIDANT CORP. 510(k) NO: K020161(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 408-845-1419
3200 LAKESIDE DR. SE DECISION MADE: 22-FEB-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAPSYSTEM SET
H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K013692(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-477-1671
10147 UMBERLAND PLACE SE DECISION MADE: 05-FEB-02
BOCA RATON, FL 33428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
HEALTHWAY PRODUCTS, INC. 510(k) NO: K012549(TRADITIONAL)
ATTN: DICK BRIGGS PHONE NO : 315-463-0240
PO BOX 2729 SE DECISION MADE: 04-FEB-02
SYRACUSE, NY 13220-2729 510(k) STATEMENT
DEVICE: HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K013611(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 01-FEB-02
FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENRAF-NONIUS ENDOMED 182 SYSTEM
HENLEY HEALTHCARE, INC. 510(k) NO: K003744(TRADITIONAL)
ATTN: REBECCA STOUT PHONE NO : 281-276-7000
120 INDUSTRIAL BLVD. SE DECISION MADE: 20-FEB-02
SUGAR LAND, TX 77478 510(k) STATEMENT
DEVICE: VENUS UNIVERSAL LIGHT CURING COMPOSITE
HERAEUS KULZER, INC. 510(k) NO: K020131(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-291-0661
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 28-FEB-02
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
HITACHI MEDICAL CORP. 510(k) NO: K013722(SPECIAL)
ATTN: WALTER WEYBURNE PHONE NO : 914-524-9711
660 WHITE PLAINS ROAD SE DECISION MADE: 11-FEB-02
TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
HITACHI MEDICAL CORP. 510(k) NO: K013723(SPECIAL)
ATTN: WALTER WEYBURNE PHONE NO : 914-524-9711
660 WHITE PLAINS ROAD SE DECISION MADE: 06-FEB-02
TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020293(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 14-FEB-02
ALLENDALE, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-M
HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K012811(TRADITIONAL)
ATTN: CINDY SHOWALTER PHONE NO : 434-979-4000
2400 HUNTER'S WAY SE DECISION MADE: 11-FEB-02
CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
HYPOGUARD USA, INC. 510(k) NO: K020232(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 12-FEB-02
EDINA, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAGON INFUSION SYSTEM
I-FLOW CORP. 510(k) NO: K020251(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 15-FEB-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCERT RADIOPAQUE BONE CEMENT
IMMEDICA, INC. 510(k) NO: K013755(TRADITIONAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262
615 7TH STREET NE SE DECISION MADE: 08-FEB-02
WASHINGTON, DC 20002 510(k) STATEMENT
DEVICE: GELZONE
IMPLANTECH ASSOCIATES, INC. 510(k) NO: K013732(TRADITIONAL)
ATTN: STEPHEN MEADE PHONE NO : 805-339-9415
2064 EASTMAN AVE., UNIT 101 SE DECISION MADE: 07-FEB-02
VENTURA, CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-588
IMPLEX CORP. 510(k) NO: K020295(SPECIAL)
ATTN: LES HEIMANN PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 12-FEB-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORION DIGITAL IMAGING SYSTEM
INFIMED, INC. 510(k) NO: K012490(TRADITIONAL)
ATTN: RALPH J FLATAU PHONE NO : 315-453-4545
121 METROPOLITAN DR. SE DECISION MADE: 12-FEB-02
LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION CPS BSSO SCREW
INION LTD. 510(k) NO: K020266(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 22-FEB-02
TAMPERE, FINLAND FIN-33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC MULTI-FIRE CLIP APPLIER
INSCOPE, LLC. 510(k) NO: K013889(TRADITIONAL)
ATTN: BRUCE WEBER PHONE NO : 305-716-7000
8210 NW 27TH ST. SE DECISION MADE: 07-FEB-02
MIAMI, FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
INSTITUT STRAUMANN AG 510(k) NO: K013891(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 05-FEB-02
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K020096(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 08-FEB-02
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: MEDSURG EQUIPMENT COVERS
INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K014239(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 19-FEB-02
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GEO STRUCTURE
INTERPORE CROSS INTL. 510(k) NO: K020048(SPECIAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 06-FEB-02
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MO
INTERPORE CROSS INTL. 510(k) NO: K020204(SPECIAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 21-FEB-02
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERG
INTERVASCULAR 510(k) NO: K013651(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-431-7240
20 WALNUT ST.; SUITE 12 SE DECISION MADE: 27-FEB-02
WELLESLEY, MA 02481 510(k) STATEMENT
DEVICE: PULSION FS LASER KERATOME
INTRALASE CORP. 510(k) NO: K013941(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 27-FEB-02
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
INTUITIVE SURGICAL, INC. 510(k) NO: K013952(TRADITIONAL)
ATTN: MICHAEL YRAMATEGUL PHONE NO : 650-237-7000
1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 28-FEB-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR. HAYS BITE GUARD
INVENTIVE RESOURCES, INC. 510(k) NO: K014079(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 22-FEB-02
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYS
INVIVO RESEARCH, INC. 510(k) NO: K002604(TRADITIONAL)
ATTN: FRANCIS X CASEY PHONE NO : 407-275-3220
12601 RESEARCH PKWY. SE DECISION MADE: 07-FEB-02
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D.SIGN 59
IVOCLAR VIVADENT, INC. 510(k) NO: K013809(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 07-FEB-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: HELIOMOLAR HB TRANSLUCENT SHADES
IVOCLAR VIVADENT, INC. 510(k) NO: K013929(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 07-FEB-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: D.SIGN 84
IVOCLAR VIVADENT, INC. 510(k) NO: K014042(TRADITIONAL)
ATTN: ANDERJEET S GULATI PHONE NO : 800-533-6825
175 PINEVIEW DR. SE DECISION MADE: 22-FEB-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: VERAVIEWEPOCS, MODEL VE
J. MORITA USA, INC. 510(k) NO: K013955(TRADITIONAL)
ATTN: WILLIAM D HARE PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 04-FEB-02
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIGROUP CATHETER EXTENDER/REPAIR KIT
JANIN GROUP, INC. 510(k) NO: K012502(TRADITIONAL)
ATTN: JOHN A NAVIS PHONE NO : 630-428-4143
505 WESTON RIDGE DR. SE DECISION MADE: 04-FEB-02
NAPERVILLE, IL 60563-3932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAS AMYLASE LIQUID REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K020282(TRADITIONAL)
ATTN: DAVID JOHNSON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 28-FEB-02
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
JENERIC/PENTRON, INC. 510(k) NO: K013542(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 14-FEB-02
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: BOND-1 C & B
JENERIC/PENTRON, INC. 510(k) NO: K013543(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-FEB-02
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: PROMOGRAN MATRIX WOUND DRESSING
JOHNSON & JOHNSON MEDICAL, LTD. 510(k) NO: K014129(TRADITIONAL)
ATTN: SERGIO J GADALETA PHONE NO : 908-218-2893
ROUTE 22 WEST SE DECISION MADE: 14-FEB-02
P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
JOSTRA AG 510(k) NO: K013944(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA ROAD SE DECISION MADE: 11-FEB-02
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
KAMIYA BIOMEDICAL CO. 510(k) NO: K014293(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 19-FEB-02
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: MODIFICATION TO DATACAPTOR
KAMM & ASSOC. 510(k) NO: K020197(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 21-FEB-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE LATEX SURGEON'S GLOVES
KANAM LATEX INDUSTRIES PVT. LTD. 510(k) NO: K013914(TRADITIONAL)
ATTN: RAVI ABRAHAM PHONE NO : 914 815 63513
K.K. RD., OOPPOOTTIL BLDGS. SE DECISION MADE: 06-FEB-02
P.O. BOX 28 510(k) STATEMENT
KOTTAYAM, KERALA, INDIA 686001
DEVICE: BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
KARL STORZ ENDOSCOPY 510(k) NO: K013107(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 26-FEB-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMETRON LC
KERR CORP. 510(k) NO: K014179(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 04-FEB-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND SOLO PLUS 4
KERR DENTAL MATERIALS CENTER 510(k) NO: K014027(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 22-FEB-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPHASE
KERR DENTAL MATERIALS CENTER 510(k) NO: K020092(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 22-FEB-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VIEWSEND MEDICAL
KLT TELECOM, INC. 510(k) NO: K013994(SPECIAL)
ATTN: KEN LOGSDON, JR. PHONE NO : 703-502-1486
14080-A SULLYFIELD CIRCLE SE DECISION MADE: 01-FEB-02
CHANTILLY, VA 20151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
KOVEN TECHNOLOGY, INC. 510(k) NO: K010452(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 12-FEB-02
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE NON-CONTACT TONOMETER, MODEL PT100
LEICA MICROSYSTEMS, INC. O.I.D. 510(k) NO: K013259(TRADITIONAL)
ATTN: FRANK J DREXELIUS PHONE NO : 716-686-4548
3374 WALDEN AVE. SE DECISION MADE: 20-FEB-02
DEPEW, NY 14043 510(k) STATEMENT
DEVICE: PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
LITTON SYSTEMS, INC. 510(k) NO: K013223(TRADITIONAL)
ATTN: GARY BYRD PHONE NO : 563-383-6299
2734 HICKORY GROVE ROAD SE DECISION MADE: 11-FEB-02
DAVENPORT, IA 52804 510(k) STATEMENT
DEVICE: LUMEND FRONTRUNNER CTO CORONARY CATHETER
LUMEND, INC. 510(k) NO: K013284(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400
400 CHESAPEAKE DR. SE DECISION MADE: 11-FEB-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
MACHNET BV 510(k) NO: K013985(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 01-FEB-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
MEDICAL COMPONENTS, INC. 510(k) NO: K012562(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 08-FEB-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURG
MEDICAL INSTRUMENTS TECHNOLOGY, IN510(k) NO: K012640(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 435-674-4010
385 NORTH 3050 EAST, SUITE B SE DECISION MADE: 28-FEB-02
ST. GEORGE, UT 84790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP
MEDTRADE PRODUCTS LIMITED 510(k) NO: K014036(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
7 THE BARNS, BRIDGEMERE SE DECISION MADE: 14-FEB-02
NANTWICH, UNITED KINGDOM CW5 7PF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMA
MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K012274(TRADITIONAL)
ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332
11811 WILLOWS RD NE SE DECISION MADE: 05-FEB-02
P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073-9706
DEVICE: MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 9
MEDTRONIC PS MEDICAL 510(k) NO: K012052(TRADITIONAL)
ATTN: JEFF HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 11-FEB-02
UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117
DEVICE: DYNA-LOK CLASSIC SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K020155(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-FEB-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSD WIRE SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K020426(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 26-FEB-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION WITH FLUOROMERGE SOFTWARE
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K020338(SPECIAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIR. SE DECISION MADE: 27-FEB-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 9210 DELIVERY CATHETER, MODEL 9210
MEDTRONIC, INC. 510(k) NO: K013963(TRADITIONAL)
ATTN: MARY E BEST PHONE NO : 763-514-4846
7000 CENTRAL AVENUE NE SE DECISION MADE: 28-FEB-02
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K014301(SPECIAL)
ATTN: LEE LEICHTER PHONE NO : 941-786-1118
7690 CAMERON CIRCLE SE DECISION MADE: 11-FEB-02
FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XERAFIT
METALOR TECHNOLOGIES USA 510(k) NO: K020062(TRADITIONAL)
ATTN: BRUCE A BARTON PHONE NO : 800-554-5504
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 14-FEB-02
NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT
DEVICE: A1CNOW FOR RX HOME USE
METRIKA, INC. 510(k) NO: K020234(SPECIAL)
ATTN: ERIKA AMMIRATI PHONE NO : 408-524-2255
510 OAKMEAD PKWY. SE DECISION MADE: 15-FEB-02
SUNNYVALE, CA 94085-4022 510(k) STATEMENT
DEVICE: A1CNOW FOR PROFESSIONAL USE
METRIKA, INC. 510(k) NO: K020235(SPECIAL)
ATTN: ERIKA AMMIRATI PHONE NO : 408-524-2255
510 OAKMEAD PKWY. SE DECISION MADE: 15-FEB-02
SUNNYVALE, CA 94085-4022 510(k) STATEMENT
DEVICE: MICROLIGHT 830 LASER SYSTEM
MICROLIGHT CORPORATION OF AMERICA 510(k) NO: K010175(TRADITIONAL)
ATTN: MICHAEL BARBOUR PHONE NO : 713-777-5477
2935 HIGHLAND LAKES SE DECISION MADE: 06-FEB-02
MISSOURI CITY, TX 77459 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MB 103 MILLENNIUM BLADES
MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K011833(TRADITIONAL)
ATTN: JERRY KAENI PHONE NO : 909-621-7646
360 EAST BONITA AVE. SE DECISION MADE: 15-FEB-02
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MB 102 MILLENNIUM BLADES
MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K020122(TRADITIONAL)
ATTN: JERRY KAENI PHONE NO : 909-621-7646
360 EAST BONITA AVE. SE DECISION MADE: 15-FEB-02
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
MINNTECH CORP. 510(k) NO: K014016(TRADITIONAL)
ATTN: LYNN LUCDERS PHONE NO : 763-553-2475
14605 28TH AVE. NORTH SE DECISION MADE: 01-FEB-02
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIDIDFIX 2.7MM BTB CROSS PIN KIT
MITEK PRODUCTS 510(k) NO: K013781(TRADITIONAL)
ATTN: JENNIFER JOHNSON PHONE NO : 781-251-2704
249 VANDERBILT AVENUE SE DECISION MADE: 06-FEB-02
NORWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXS-63 SMALL EXTREMITY ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K020036(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 01-FEB-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: WAVELENGHT ULTRASOUND LOTION
NATIONAL THERAPY PRODUCTS INC. 510(k) NO: K013212(TRADITIONAL)
ATTN: PAUL L HOOEY PHONE NO : 905 264 5600
2-191 ROWNTREE DAIRY RD. SE DECISION MADE: 25-FEB-02
WOODBRIDGE, ONTARIO, CANADA LHL 8B510(k) STATEMENT
DEVICE: VASCUPUNCTURE ACCESS WIRE
NEO METRICS, INC. 510(k) NO: K012861(TRADITIONAL)
ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440
15301 HIGHWAY 55 WEST SE DECISION MADE: 05-FEB-02
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DFINER UROLOGICAL CATHETER
NEOSEED TECHNOLOGY,LLC 510(k) NO: K013360(TRADITIONAL)
ATTN: MARK KIERAS PHONE NO : 978-463-4086
22 HILL STREET SE DECISION MADE: 20-FEB-02
NEWBURYPORT, MA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-3300 LASER DIODE PHOTOCOAGULATOR
NIDEK, INC. 510(k) NO: K013760(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 11-FEB-02
LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
NIDEK, INC. 510(k) NO: K013864(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 08-FEB-02
LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE PHOX ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K014295(TRADITIONAL)
ATTN: PAUL W MAC DONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 28-FEB-02
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: INCLUDER CLAMP
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K010694(TRADITIONAL)
ATTN: TERRY BUELNA PHONE NO : 408-350-9911
10231 BUBB RD. SE DECISION MADE: 11-FEB-02
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "ARIEL" RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND
NOVASYS MEDICAL, INC. 510(k) NO: K013730(TRADITIONAL)
ATTN: THOMAS C WEHMAN PHONE NO : 408-720-6321
687 NO. PASTORIA AVENUE SE DECISION MADE: 06-FEB-02
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSENSOR
NOVUS MONITORING LTD 510(k) NO: K013930(TRADITIONAL)
ATTN: PETER F GIBSON PHONE NO : 441 264 711080
ABBOTTS ANN, ANDOVER SE DECISION MADE: 20-FEB-02
HAMPSHIRE 510(k) SUMMARY AVAILABLE FROM FDA
UNITED KINGDOM, UNITED KINGDOM SP11 7BH
DEVICE: NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
NXSTAGE MEDICAL, INC. 510(k) NO: K013655(TRADITIONAL)
ATTN: KAREN ST. ONGE PHONE NO : 978-687-4700
439 SOUTH UNION STREET SE DECISION MADE: 04-FEB-02
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
S. LAWRENCE, MA 01843
DEVICE: OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRA
OLYMPUS AMERICA, INC. 510(k) NO: K014015(TRADITIONAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 08-FEB-02
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRA
OLYMPUS AMERICA, INC. 510(k) NO: K014032(TRADITIONAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 08-FEB-02
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
ON SITE GAS SYSTEMS INC. 510(k) NO: K020362(TRADITIONAL)
ATTN: C. BARTON GULLONG PHONE NO : 860-667-8888
35 BUDNEY ROAD SE DECISION MADE: 12-FEB-02
BUDNEY PARK INDUSTRIAL 510(k) SUMMARY AVAILABLE FROM FDA
NEWINGTON, CT 06111
DEVICE: OVUS CAPLESS SAFETY NEEDLE
OVUS SYSTEMS 510(k) NO: K013006(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PKWY, STE 625 SE DECISION MADE: 06-FEB-02
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADPRO, MODEL 2603
PADPRO LLC. 510(k) NO: K020288(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O.BOX 7007 SE DECISION MADE: 27-FEB-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STONELITH, MODEL V5
PCK ELECTRONIC INDUSTRY AND TRADE 510(k) NO: K011106(TRADITIONAL)
ATTN: CENGIZ KABAKCI PHONE NO : 903 124 916010
59/1 SANCAK, CANKAYA SE DECISION MADE: 11-FEB-02
ANKARA, TURKEY 06550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K013640(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 914-365-0700
30 RAMLAND ROAD SE DECISION MADE: 04-FEB-02
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K014261(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 12-FEB-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO M2376A DEVICELINK SYSTEM
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K020494(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. MS 0491 SE DECISION MADE: 21-FEB-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODUL
PHOENIX DIAGNOSTICS, INC. 510(k) NO: K020129(TRADITIONAL)
ATTN: RAM NUNNA PHONE NO : 508-655-8310
8 TECH CIRCLE SE DECISION MADE: 01-FEB-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENOIX ISE REAGENTS FOR OLYMPUS AU SERIES
PHOENIX DIAGNOSTICS, INC. 510(k) NO: K020148(TRADITIONAL)
ATTN: RAM NUNNA PHONE NO : 508-655-8310
8 TECH CIRCLE SE DECISION MADE: 04-FEB-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIM GLIDING NAIL SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K020240(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 22-FEB-02
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABYCOM
PMG MEDICA LTD. 510(k) NO: K013547(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 299 32768
POB 6718 SE DECISION MADE: 20-FEB-02
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
POLYMEDICA PHARMACEUTICALS, U.S.A.510(k) NO: K014167(TRADITIONAL)
ATTN: PATRICIA COLLINS PHONE NO : 781-933-2020
11 STATE STREET SE DECISION MADE: 19-FEB-02
WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTEC
PORTEX, INC. 510(k) NO: K014073(TRADITIONAL)
ATTN: BRAIN E FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 13-FEB-02
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOSIS HELMET MOLDING
PRECISION PROSTHETICS & ORTHOTICS,510(k) NO: K013700(TRADITIONAL)
ATTN: CONNIE FICKLIN PHONE NO : 952-946-8080
5353 WAYZATA BLVD. STE 505 SE DECISION MADE: 05-FEB-02
MINNEAPOLIS, MN 55416-1334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIME-DENT HEMA DESENSITIZER
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K013970(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 19-FEB-02
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: VINYL EXAMINATION GLOVES STERILE POWEDERED
PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K020044(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 914 844 21983
PLOT NO:14-A COCHIN SPECIAL SE DECISION MADE: 26-FEB-02
ECONOMIC ZONE 510(k) STATEMENT
KAKKANAD, KOCHI, KERALA, INDIA 682 030
DEVICE: JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
PROGENY, INC. 510(k) NO: K020070(TRADITIONAL)
ATTN: ALAN KREMA PHONE NO : 847-850-3800
1407 BARCLAY BLVD. SE DECISION MADE: 01-FEB-02
BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
PSYCHEMEDICS CORP. 510(k) NO: K011275(TRADITIONAL)
ATTN: THOMAS CAIRNS PHONE NO : 617-868-7455
5832 UPLANDER WAY SE DECISION MADE: 11-FEB-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL,
PT. MAJA AGUNG LATEXINDO 510(k) NO: K013996(TRADITIONAL)
ATTN: EMMY T JOENG PHONE NO : 909-591-8855
5445 DANIEL STREET SE DECISION MADE: 26-FEB-02
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
PULPDENT CORP. 510(k) NO: K014059(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 27-FEB-02
WATERTOWN, MA 02472 510(k) STATEMENT
DEVICE: PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
PULPDENT CORP. 510(k) NO: K020115(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 28-FEB-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R & D BODY FLUID CONTROL
R & D SYSTEMS, INC. 510(k) NO: K020229(TRADITIONAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413
614 MCKINLEY PL., N.E. SE DECISION MADE: 06-FEB-02
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
RADCO DATA AB 510(k) NO: K012439(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 06-FEB-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRARED EAR THERMOMETER, MODELS TH88 SERIES
RADIANT INNOVATION, INC. 510(k) NO: K020504(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD SE DECISION MADE: 28-FEB-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: RESPIRONICS HEATED HUMIDIFIER
RESPIRONICS, INC. 510(k) NO: K012633(TRADITIONAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE SE DECISION MADE: 28-FEB-02
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENAMEL BONDING SYSTEM
RITE-DENT MANUFACTURING CORP. 510(k) NO: K020050(TRADITIONAL)
ATTN: CESAR E VELIZ PHONE NO : 305-693-8626
1056 EAST 33RD ST. SE DECISION MADE: 14-FEB-02
HIALEAH, FL 33013-3526 510(k) STATEMENT
DEVICE: ROCHE COBAS TAQMAN ANALYZER
ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K012966(TRADITIONAL)
ATTN: GARY S RIORDAN PHONE NO : 925-730-8350
4300 HACIENDA DRIVE SE DECISION MADE: 01-FEB-02
PLEASANTON, CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH MILLER-ABBOTT TUBE
RUSCH INTL. 510(k) NO: K010797(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706
50 PLANTATION DRIVE SE DECISION MADE: 26-FEB-02
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH CANTOR TUBE
RUSCH INTL. 510(k) NO: K010798(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-0204
50 PLANTATION DRIVE SE DECISION MADE: 26-FEB-02
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH MEMORY BAG
RUSCH INTL. 510(k) NO: K013872(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-7706
50 PLANTATION DRIVE SE DECISION MADE: 12-FEB-02
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALTER LABS MODIFIED NEBUTECH NEBULIZER
SALTER LABS 510(k) NO: K014056(SPECIAL)
ATTN: DUANE KAZAL PHONE NO : 661-854-3166
100 W. SYCAMORE ROAD SE DECISION MADE: 01-FEB-02
ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANDHILL SCIENTIFIC PEDIATEC PH PROBE
SANDHILL SCIENTIFIC, INC. 510(k) NO: K013951(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279
4655 KIRKWOOD CT SE DECISION MADE: 28-FEB-02
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ISOBAR SPINAL SYSTEM
SCIENT'X 510(k) NO: K020245(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 01-FEB-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROLAB II, MODEL 29
SDI DIAGNOSTICS, INC. 510(k) NO: K013812(TRADITIONAL)
ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033
10 HAMPDEN DR. SE DECISION MADE: 11-FEB-02
EASTON, MA 02375 510(k) STATEMENT
DEVICE: PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
SEDECAL S.A. 510(k) NO: K020436(ABBREVIATED)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 22-FEB-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSAID
SENSIDYNE, INC. 510(k) NO: K011974(TRADITIONAL)
ATTN: GEORGE MASON PHONE NO : 727-530-3602
16333 BAY VISTA DRIVE SE DECISION MADE: 12-FEB-02
CLEARWATER, FL 33760 510(k) STATEMENT
DEVICE: PYLORITEK VP TEST KIT 5140VP
SERIM RESEARCH CORP. 510(k) NO: K014038(TRADITIONAL)
ATTN: PATRICIA RUPUCHOCK PHONE NO : 574-264-3440
23565 REEDY DR. SE DECISION MADE: 08-FEB-02
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPA
SEWOON MEDICAL CO., LTD. 510(k) NO: K013276(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 15-FEB-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE CO
SGMP CO., LTD. 510(k) NO: K020317(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 14-FEB-02
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
SHEEN MORE ENT. CO., LTD. 510(k) NO: K013998(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 13-FEB-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K014077(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 04-FEB-02
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LA
SIAM SEMPERMED CORP. LTD. 510(k) NO: K014110(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 28-FEB-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLY
SIAM SEMPERMED CORP. LTD. 510(k) NO: K014112(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 28-FEB-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY SC 6002XL MODIFICATIONS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K020144(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVENUE SE DECISION MADE: 15-FEB-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K020277(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 19-FEB-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K013826(TRADITIONAL)
ATTN: SANDRA ROBINSON PHONE NO : 732-321-3243
186 WOOD AVENUE SOUTH SE DECISION MADE: 01-FEB-02
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIA X/XS ULTRASOUND SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K020353(TRADITIONAL)
ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229
22010 SE 51ST STREET SE DECISION MADE: 13-FEB-02
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
SIERRA DIAGNOSTIC, L.L.C. 510(k) NO: K013819(TRADITIONAL)
ATTN: DONALD R STONE PHONE NO : 202-778-9067
1800 MASSACHUSETTS AVE., NW SE DECISION MADE: 28-FEB-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036-1221
DEVICE: SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
SIGMA DIAGNOSTICS, INC. 510(k) NO: K020109(TRADITIONAL)
ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 06-FEB-02
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANDHELD GAMMA FINDER (HGF)
SILICON INSTRUMENTS GMHB 510(k) NO: K013751(TRADITIONAL)
ATTN: THOMAS GOEBEL PHONE NO : 493 063 992360
OSTENDSTRASSE 1 SE DECISION MADE: 06-FEB-02
BERLIN, GERMANY D-12459 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHE
SIMS PORTEX LTD. 510(k) NO: K012277(TRADITIONAL)
ATTN: STEVEN OGILVIE PHONE NO : 44 130 3260551
HYTHE SE DECISION MADE: 11-FEB-02
HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
SIMS PORTEX, INC. 510(k) NO: K014115(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 27-FEB-02
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS ELECTROBLADE RESECTOR
SMITH & NEPHEW, INC. 510(k) NO: K012314(TRADITIONAL)
ATTN: TIM CRABTREE PHONE NO : 978-749-1068
160 DASCOMB RD. SE DECISION MADE: 01-FEB-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLIC
SMITH & NEPHEW, INC. 510(k) NO: K012938(ABBREVIATED)
ATTN: TRUDE C NAFF PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 08-FEB-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO-GLIDE
SONOTECH, INC. 510(k) NO: K013701(TRADITIONAL)
ATTN: MARGARET J LARSON PHONE NO : 360-671-9121
774 MARINE DR. SE DECISION MADE: 04-FEB-02
BELLINGHAM, WA 98225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRAL'S TROPONIN I
SPECTRAL DIAGNOSTICS, INC. 510(k) NO: K014105(TRADITIONAL)
ATTN: NISAR A SHAIKH PHONE NO : 416 626 3233
135-2 THE WEST MALL SE DECISION MADE: 01-FEB-02
TORONTO, ONTARIO, CANADA M9C1C2 510(k) STATEMENT
DEVICE: BACFIX SPINAL FIXATION SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K013887(TRADITIONAL)
ATTN: DAVID M HOPPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 12-FEB-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K013979(SPECIAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 13-FEB-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI-T SPINAL SYSTEM
SPINEVISION, INC. 510(k) NO: K013301(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD.; STE 1500 SE DECISION MADE: 13-FEB-02
ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
SPINEVISION, INC. 510(k) NO: K013312(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD.; STE 1500 SE DECISION MADE: 13-FEB-02
ATLANTA, GA 30319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOCALEX
STEPHEN M KORAL, DMD 510(k) NO: K013993(TRADITIONAL)
ATTN: STEPHEN M KORAL PHONE NO : 303-443-4984
2006 BROADWAY SE DECISION MADE: 22-FEB-02
BOULDER, CO 80302 510(k) STATEMENT
DEVICE: REPROCESSED ELECTRIC SNARES
STERILMED, INC. 510(k) NO: K012555(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 14-FEB-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED STONE RETRIEVAL BASKETS
STERILMED, INC. 510(k) NO: K012581(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE N., SUITE 100 SE DECISION MADE: 14-FEB-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ENDOSCOPIC ELECTROSURGICAL BIOPSY FORCEPS
STERILMED, INC. 510(k) NO: K012596(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 763-488-3400
11400 73RD AVE N., SUITE 100 SE DECISION MADE: 14-FEB-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILMED REPROCESSED COMPRESSION SLEEVES
STERILMED, INC. 510(k) NO: K012597(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 11-FEB-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ENDOSCOPIC ELECTRODES
STERILMED, INC. 510(k) NO: K012685(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 14-FEB-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRIFUGAL PUMP
STOCKERT INSTRUMENTE GMBH 510(k) NO: K011838(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 05-FEB-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
SULZER SPINE-TECH 510(k) NO: K020196(SPECIAL)
ATTN: KRISTYN M BENSON PHONE NO : 952-830-6273
7375 BUSH LAKE RD. SE DECISION MADE: 15-FEB-02
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVE
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K013953(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 72328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 26-FEB-02
BUKIT RAHMAN PUTRA 510(k) STATEMENT
SUNGAI BULOH, SELANGOR, MALAYSIA 47000
DEVICE: FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
SURVIVALINK CORP. 510(k) NO: K011901(TRADITIONAL)
ATTN: JOHN CARLINE PHONE NO : 952-939-2978
5420 FELTL RD. SE DECISION MADE: 01-FEB-02
MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPFIL
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013895(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 04-FEB-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTER
SYNTERMED, INC. 510(k) NO: K014033(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
245 OWENS DRIVE SE DECISION MADE: 22-FEB-02
ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K020493(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3275480
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 26-FEB-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 0252360
DEVICE: FAST SET PUTTY
SYNTHES (USA) 510(k) NO: K012589(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 07-FEB-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES METALLIC SPIKED WASHERS
SYNTHES (USA) 510(k) NO: K013806(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-FEB-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CRANIAL PLATES
SYNTHES (USA) 510(k) NO: K020087(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 20-FEB-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTECH B990K VIVI WHEELCHAIR
TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K014198(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 01-FEB-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K020284(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 08-FEB-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: OMEGATRAC, MODEL Z105
TEFTEC CORP. 510(k) NO: K013307(TRADITIONAL)
ATTN: THOMAS E FINCH, III PHONE NO : 210-477-0330
12450 NETWORK BLVD. SE DECISION MADE: 08-FEB-02
SAN ANTONIO, TX 78249 510(k) STATEMENT
DEVICE: TEKNO-MEDICAL OBSTETRICAL FORCEPS
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH510(k) NO: K013747(ABBREVIATED)
ATTN: MARKUS DENK PHONE NO : 004 974 6496600
KAISERSTR 9 SE DECISION MADE: 11-FEB-02
TUNINGEN, BADEN-WURTENBERG, GERMAN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TRANSSEPTAL INTRODUCER SET
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K020090(SPECIAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 11-FEB-02
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ES
TIMM MEDICAL TECHNOLOGIES, INC. 510(k) NO: K020082(SPECIAL)
ATTN: CHRIS HADLAND PHONE NO : 952-947-9410
6585 CITY WEST PKWY. SE DECISION MADE: 05-FEB-02
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTE
TOP QUALITY MFG., INC. 510(k) NO: K013254(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 04-FEB-02
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TS
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K020385(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 15-FEB-02
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K014258(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 19-FEB-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: AEROPEP
TRUDELL MEDICAL INTL. 510(k) NO: K012368(TRADITIONAL)
ATTN: TOM HOLBROOK PHONE NO : 519 455 7060
725 THIRD ST. SE DECISION MADE: 12-FEB-02
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: SPIRABRUSH CX BIOPSY INSTRUMENT
TRYLON CORP. 510(k) NO: K011488(TRADITIONAL)
ATTN: MARTIN LONKY PHONE NO : 310-327-8820
970 WEST 190TH ST., SUITE 850 SE DECISION MADE: 22-FEB-02
TORRANCE, CA 90502-1037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
TUTA HEALTHCARE PTY LIMITED 510(k) NO: K020083(TRADITIONAL)
ATTN: OMID SOURESRAFIL PHONE NO : 612 942 70300
318-332 BURNS BAY ROAD SE DECISION MADE: 12-FEB-02
LANE COVE 510(k) SUMMARY AVAILABLE FROM FDA
SYDNEY NSW, AUSTRALIA 2066
DEVICE: BRACE EZE
UDENT, INC. 510(k) NO: K020009(TRADITIONAL)
ATTN: MANAR JAMAL PHONE NO : 909-623-0409
676 FAIRPLEX DRIVE SE DECISION MADE: 11-FEB-02
POMONA, CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARPLANE EASY OVULATION TEST
UNIPATH LTD. 510(k) NO: K013874(TRADITIONAL)
ATTN: STEVEN H ARMSTRONG PHONE NO : 212-418-8515
390 PARK AVENUE SE DECISION MADE: 19-FEB-02
NEW YORK, NY 10022-4698 510(k) STATEMENT
DEVICE: SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
UNITED STATES SURGICAL 510(k) NO: K020352(SPECIAL)
ATTN: TINA RIDEOUT PHONE NO : 203-845-4520
150 GLOVER AVE. SE DECISION MADE: 26-FEB-02
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARK 5000 QUADRATURE SHOULDER COIL
USA INSTRUMENTS, INC. 510(k) NO: K013854(TRADITIONAL)
ATTN: TORI MASIELLA PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 06-FEB-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTL BODY / SPINE ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K014086(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 05-FEB-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VCS-A SERIES CLAMP
VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K011863(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949-488-8700
32236- E PASEO ADELANTO SE DECISION MADE: 15-FEB-02
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANVAS N-VAS-D 2.0
VASSOL INC. 510(k) NO: K014011(TRADITIONAL)
ATTN: LYNETTE L HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 05-FEB-02
FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
VENTLAB CORP. 510(k) NO: K020281(SPECIAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-492-2636
2934 HWY. 601 NORTH SE DECISION MADE: 11-FEB-02
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: MODIFICATION TO VISTA STEREOSCOPE SYSTEM
VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K020301(SPECIAL)
ATTN: GRAHAM BAILLIE PHONE NO : 508-366-3668
134 FLANDERS RD. SE DECISION MADE: 12-FEB-02
WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CL
VISTAKON 510(k) NO: K013973(TRADITIONAL)
ATTN: JAMES W PARZIALE PHONE NO : 904-443-1808
7500 CENTURION PARKWAY SE DECISION MADE: 26-FEB-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32256
DEVICE: UROVYSION BLADDER CANCER RECURRENCE KIT
VYSIS 510(k) NO: K013785(ABBREVIATED)
ATTN: RUSSEL K ENNS PHONE NO : 630-271-7040
3100 WOODCREEK DR. SE DECISION MADE: 08-FEB-02
DOWNERS GROVE, IL 60515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ SELF DRILLING SCREWS
WALTER LORENZ SURGICAL, INC. 510(k) NO: K013954(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 28-FEB-02
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ BLUE DEVICE
WALTER LORENZ SURGICAL, INC. 510(k) NO: K020407(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 22-FEB-02
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO WARTNER WART REMOVAL SYSTEM
WARTNER MEDICAL PRODUCTS 510(k) NO: K011708(TRADITIONAL)
ATTN: NANCY LUM-WILSON PHONE NO : 905 794 3339
25 BELLINI AVE. SE DECISION MADE: 20-FEB-02
BRAMPTON, ONTARIO, CANADA L6T 3Z8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WMT MODULAR ULNAR HEAD IMPLANT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K020274(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 22-FEB-02
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERI
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K014288(TRADITIONAL)
ATTN: MOHD H HUSSEIN PHONE NO : 603 870 69788
LOT11 JALAN2 PERUSAHAAN BANDAR SE DECISION MADE: 13-FEB-02
KAWASAN BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG, SELANGOR, MALAYSIA 43900
TOTAL 510(k)s THIS PERIOD 314
TOTAL WITH SUMMARIES 251
TOTAL WITH STATEMENTS 63
Updated 4/28/2004
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