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Medical Devices
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April 2002 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-APR-2002 THROUGH 30-APR-2002
DEVICE: IMMEDIATE STABILIZING DEVICE (ISD)
"O" CO., INC. 510(k) NO: K011524(TRADITIONAL)
ATTN: DAVID D DALISE PHONE NO : 800-228-0477
600 PAISANO, N.E., SUITE A SE DECISION MADE: 10-APR-02
ALBUQUERQUE, NM 87123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
3M CO. 510(k) NO: K020589(TRADITIONAL)
ATTN: JOANN L HUEHN PHONE NO : 651-733-9209
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 22-APR-02
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADPER PROMPT
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K020946(SPECIAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 04-APR-02
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APC PLUS ADHESIVE
3M UNITEK 510(k) NO: K020394(TRADITIONAL)
ATTN: MARLYN SCHEFF PHONE NO : 626-574-4496
2724 SOUTH PECK RD. SE DECISION MADE: 12-APR-02
MONROVIA, CA 91016 510(k) STATEMENT
DEVICE: ETEST ERTAPENEM
AB BIODISK 510(k) NO: K020748(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0768
DALVAGEN 10 SE DECISION MADE: 29-APR-02
SOLNA, SWEDEN S-169 56 510(k) STATEMENT
DEVICE: MOTION TRACKING
ACCURAY, INC. 510(k) NO: K020294(TRADITIONAL)
ATTN: DONALD E CADDES PHONE NO : 408-522-3740
570 DEL REY AVE. SE DECISION MADE: 22-APR-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST PLUS 4 ANGIOGRAPHIC CATHETER
ACIST MEDICAL SYSTEMS 510(k) NO: K021015(SPECIAL)
ATTN: CARL M BEAURLINE PHONE NO : 612-995-9319
7450 FLYING CLOUDS DR. SE DECISION MADE: 26-APR-02
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MOD
ACKRAD LABORATORIES 510(k) NO: K020951(SPECIAL)
ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6390
70 JACKSON DR. SE DECISION MADE: 16-APR-02
CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPH
ACKRAD LABORATORIES 510(k) NO: K020954(SPECIAL)
ATTN: RICHARD HETTENBACH PHONE NO : 908-276-6390
70 JACKSON DR. SE DECISION MADE: 24-APR-02
CRANFORD, NJ 07016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
ADVANCED HEALTHCARE LTD. 510(k) NO: K020376(TRADITIONAL)
ATTN: PERRY KASHFIAN PHONE NO : 818-362-2600
13161 TELFAIR AVE. SE DECISION MADE: 09-APR-02
SYLMAR, CA 91342 510(k) STATEMENT
DEVICE: REPROCESSED USED DISPOSABLE BIOPSY FORCEPS
ADVEN MEDICAL 510(k) NO: K012699(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 17-APR-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPILOT 2
AESCULAP, INC. 510(k) NO: K013569(TRADITIONAL)
ATTN: GEORG KELLER PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 04-APR-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIETHKE SHUNT SYSTEM
AESCULAP, INC. 510(k) NO: K020728(SPECIAL)
ATTN: JOYCE KILROY PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 05-APR-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
ALBA-WALDENSIAN, INC. 510(k) NO: K020592(TRADITIONAL)
ATTN: DAVID BOWMAN PHONE NO : 865-354-0410
425 NORTH GATEWAY AVE SE DECISION MADE: 03-APR-02
ROCKWOOD, TN 37854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICHROME HEPARIN (ANTI-FIIA)
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K013637(TRADITIONAL)
ATTN: JOHN BERRYMAN PHONE NO : 203-661-0000
222 RAILROAD AVE. SE DECISION MADE: 16-APR-02
GREENWICH, CT 06830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY
APEX DENTAL MATERIALS, INC. 510(k) NO: K020570(TRADITIONAL)
ATTN: CHRIS KULTON PHONE NO : 847-490-1014
603 BERKLEY COURT SE DECISION MADE: 24-APR-02
SCHAUMBURG, IL 60194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHECKCUP IMMUNOASSAY SYSTEM FOR DRUGS OF ABUSE
APPLIED BIOTECH, INC. 510(k) NO: K021093(SPECIAL)
ATTN: STEVE WORCESTER PHONE NO : 858-587-6771
10237 FLANDERS CT. SE DECISION MADE: 24-APR-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: WOUND PROTECTOR/RETRACTOR
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K020435(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 15-APR-02
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LA
AR ALLIANCE HEALTHCARE SDN. BHD. 510(k) NO: K020838(TRADITIONAL)
ATTN: CHAU CHOON CHUAN PHONE NO : 60 04 5937616
8, LORONG INDUSTRI 11, KAWASAN SE DECISION MADE: 23-APR-02
PERINDUSTRIAN BUKIT PANCHOR, 510(k) STATEMENT
NIBONG TEBAL, PULAU PINANG, MALAYSIA 14300
DEVICE: CARIS MINITOME BIOPSY INSTRUMENT
ARTEMIS MEDICAL, INC. 510(k) NO: K020024(TRADITIONAL)
ATTN: ALLAN L ABATI PHONE NO : 510-259-3150
21021 CORSAIR BLVD. SE DECISION MADE: 03-APR-02
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHR
ARTHREX, INC. 510(k) NO: K020043(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 02-APR-02
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER COR
ARTHROCARE CORP. 510(k) NO: K020832(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 09-APR-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RH
ATRICURE, INC. 510(k) NO: K020919(SPECIAL)
ATTN: MARK L FRIEDMAN PHONE NO : 513-755-4105
6033 SCHUMACHER PARK DRIVE SE DECISION MADE: 19-APR-02
WEST CHESTER, OHIO, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRION MEDICAL QL FLUID DISPENSING SYRINGE
ATRION MEDICAL PRODUCTS, INC. 510(k) NO: K020333(TRADITIONAL)
ATTN: DAN CLARK PHONE NO : 256-586-1580
1426 CURT FRANCIS RD. SE DECISION MADE: 25-APR-02
ARAB, AL 35016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTA SST BIFURCATED GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K020767(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 03-APR-02
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
AZARY TECHNOLOGIES LLC. 510(k) NO: K013672(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 08-APR-02
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL LE
BARCO NV 510(k) NO: K020058(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O. BOX 12038 SE DECISION MADE: 04-APR-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MFCD 118I
BARCO NV 510(k) NO: K020059(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O. BOX 12038 SE DECISION MADE: 03-APR-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGEDESK
BARCO NV 510(k) NO: K020061(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O. BOX 12038 SE DECISION MADE: 03-APR-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGID GAS PERMEABLE CONTACT LENS
BAUSCH & LOMB INCORPORATED 510(k) NO: K013762(TRADITIONAL)
ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638
1400 N. GOODMAN STREET SE DECISION MADE: 03-APR-02
PO BOX 30450 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14603-0450
DEVICE: GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
BAYER GROUP DIAGNOSTICS 510(k) NO: K020208(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928
1884 MILES AVENUE SE DECISION MADE: 29-APR-02
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46515-0070
DEVICE: GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
BAYER GROUP DIAGNOSTICS 510(k) NO: K020210(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 574-262-6928
1884 MILES AVENUE SE DECISION MADE: 30-APR-02
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46515-0070
DEVICE: BCI 3180 PULSE OXIMETER
BCI, INC. 510(k) NO: K020350(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 30-APR-02
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013621(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 16-APR-02
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTEC MGIT 960 SIRE KITS
BECTON, DICKINSON AND COMPANY 510(k) NO: K014123(TRADITIONAL)
ATTN: JODY J HOFFMANN PHONE NO : 410-316-4192
7 LOVETON CIR. SE DECISION MADE: 19-APR-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K020323(TRADITIONAL)
ATTN: BRADFORD M SPRING PHONE NO : 410-316-4206
7 LOVETON CIR. SE DECISION MADE: 04-APR-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYMPHA VISION-EXPERT
BEXLEY TRADING, INC. 510(k) NO: K003896(ABBREVIATED)
ATTN: MICHAEL ZMUDA PHONE NO :
1105 BUCKBRUSH DR SE DECISION MADE: 24-APR-02
FOLSOM, CA 95630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
BIO-RAD 510(k) NO: K020610(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO ROAD SE DECISION MADE: 22-APR-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK HEMOSTASIS, MODELS 798, 799
BIO-RAD 510(k) NO: K020878(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO ROAD SE DECISION MADE: 15-APR-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE CHEMISTRY CONTROL
BIO-RAD LABORATORIES, INC. 510(k) NO: K020817(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO ROAD SE DECISION MADE: 12-APR-02
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
BIOLITEC, INC. 510(k) NO: K020099(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 11-APR-02
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT FA CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K020813(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 17-APR-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT FN CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K020815(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 18-APR-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT PF CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K020923(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 18-APR-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT SA CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K020931(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 18-APR-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT SN CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K021123(TRADITIONAL)
ATTN: RON SANYAL PHONE NO : 919-620-2373
100 RODOLPHE STREET SE DECISION MADE: 26-APR-02
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020221(TRADITIONAL)
ATTN: LOMNIE WITHAM PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 02-APR-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NBX - NON-BRIDGING EXTERNAL FIXATOR
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020905(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 15-APR-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FE
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020963(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 16-APR-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER TEK II
BIOMET, INC. 510(k) NO: K020761(SPECIAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 03-APR-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0578
DEVICE: DISTAL RADIUS PLATING SYSTEM
BIOMET, INC. 510(k) NO: K020819(TRADITIONAL)
ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 22-APR-02
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
BIOMET, INC. 510(k) NO: K020970(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 04-APR-02
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0578
DEVICE: SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT
BIOSAFE LABORATORIES, INC. 510(k) NO: K012221(TRADITIONAL)
ATTN: JACK A MAGGIORE PHONE NO : 773-693-0400
100 FIELD DRIVE #240 SE DECISION MADE: 03-APR-02
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF
BIOSOUND ESAOTE, INC. 510(k) NO: K014168(TRADITIONAL)
ATTN: COLLEEN H DENSMORE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 25-APR-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABP-2000 G-3
BIOTRAC, INC. 510(k) NO: K021029(TRADITIONAL)
ATTN: JAIME GUTTMAN PHONE NO : 305-594-7474
7215 N.W. 46TH STREET SE DECISION MADE: 12-APR-02
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP
BIOTRONIK, INC. 510(k) NO: K010281(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 09-APR-02
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRD TBIRD VELA VENTILATOR
BIRD PRODUCTS CORP. 510(k) NO: K020746(SPECIAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 22-APR-02
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
BLACKSTONE MEDICAL, INC. 510(k) NO: K020674(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 03-APR-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLADEWORKS MICROKERATOME BLADE, MODEL 7061
BLADE WORKS, INC. 510(k) NO: K020079(TRADITIONAL)
ATTN: MARK MOYER PHONE NO : 760-471-2427
1816 TOWHEE STREET SE DECISION MADE: 19-APR-02
SAN MARCOS, CA 92069 510(k) STATEMENT
DEVICE: MODIFICATION TO TRELEX MESH SURGICAL MESH
BOSTON SCIENTIFIC CORP. 510(k) NO: K020110(ABBREVIATED)
ATTN: LORRAINE M HANLEY PHONE NO : 508-650-8172
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 03-APR-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 A
BOSTON SCIENTIFIC CORP. 510(k) NO: K020765(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 05-APR-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER
BOSTON SCIENTIFIC CORP. 510(k) NO: K020824(SPECIAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 12-APR-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRA COOLED SURGICAL PROBE, MODEL 1596X
BOSTON SCIENTIFIC CORP. 510(k) NO: K021046(SPECIAL)
ATTN: SUSAN POOL PHONE NO : 408-985-3608
2710 ORCHARD PKWY. SE DECISION MADE: 16-APR-02
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR
BOSTON SCIENTIFIC CORP. 510(k) NO: K021213(SPECIAL)
ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 19-APR-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIN CARE 4200
BREG, INC. 510(k) NO: K020988(SPECIAL)
ATTN: KATHLEEN BARBER PHONE NO : 760-599-3000
2611 COMMERCE WAY SE DECISION MADE: 04-APR-02
VISTA, CA 92083 510(k) STATEMENT
DEVICE: BUSSE UMBILICAL CORD CLAMP CUTTER
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K021055(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 29-APR-02
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
C.R. BARD, INC. 510(k) NO: K020682(SPECIAL)
ATTN: CAROL VIERLING PHONE NO : 770-385-2347
13183 HARLAND DR. SE DECISION MADE: 02-APR-02
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROJET MODEL # CD4 AND CD4/20
CANE S.R.I. 510(k) NO: K013776(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 26-APR-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROJET CRONO
CANE SRL 510(k) NO: K013234(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 26-APR-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING OF HEARTS EXPRESS + AF MONITOR
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K020825(SPECIAL)
ATTN: ALDEN KAY PHONE NO : 858-777-2200
6779 MESA RIDGE ROAD SE DECISION MADE: 05-APR-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121-2909
DEVICE: GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K020366(TRADITIONAL)
ATTN: ANGELA HALWAS PHONE NO : 250 744 1822
3060 CEDAR HILL ROAD SE DECISION MADE: 30-APR-02
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
VICTORIA, B.C., CANADA V8T 3J5
DEVICE: CARDIOVENTION CORX SYSTEM, MODEL FG 0001
CARDIOVENTION, INC. 510(k) NO: K012325(TRADITIONAL)
ATTN: TESSA YAMUT PHONE NO : 408-844-5130
3045 STENDER WAY SE DECISION MADE: 09-APR-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE TRGLYCERIDE
CARESIDE, INC. 510(k) NO: K020488(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 15-APR-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UTERINE INJECTOR
CATHETER RESEARCH, INC. 510(k) NO: K020292(TRADITIONAL)
ATTN: JOHN A STEEN PHONE NO : 317-872-0074
6131 WEST 80TH STREET SE DECISION MADE: 17-APR-02
INDIANAPOLIS, IN 46278 510(k) STATEMENT
DEVICE: EMULATE FAST SET AND EMULATE REGULAR SET
CAVEX HOLLAND B.V. 510(k) NO: K020242(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 312 353 07700
PO BOX 852 SE DECISION MADE: 17-APR-02
HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT
DEVICE: QAB2A IGM ELISA KIT
CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K020694(TRADITIONAL)
ATTN: NEIL B STRINGER PHONE NO : 44 151 3488023
MANAGEMENT CENTRE, INWARD WAY SE DECISION MADE: 19-APR-02
ELLESMERE PORT 510(k) STATEMENT
CHESHIRE, UNITED KINGDOM CH65 3EN
DEVICE: QAB2A IGG ELISA KIT
CHESHIRE DIAGNOSTICS LTD. 510(k) NO: K020695(TRADITIONAL)
ATTN: NEIL B STRINGER PHONE NO : 44 151 3488023
MANAGEMENT CENTRE, INWARD WAY SE DECISION MADE: 19-APR-02
ELLESMERE PORT 510(k) STATEMENT
CHESHIRE, UNITED KINGDOM CH65 3EN
DEVICE: ISAAC 1.5 T MR SYSTEM
CHI, INC. 510(k) NO: K020268(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
C/O C.L. MCINTOSH SE DECISION MADE: 25-APR-02
12300 TWINBROOK PKWY 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: AQUIFY LENS COMFORT DROPS
CIBA VISION CORP. 510(k) NO: K013204(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 03-APR-02
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL D
CIBA VISION CORP. 510(k) NO: K020139(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924
11460 JOHNS CREEK PKWY. SE DECISION MADE: 09-APR-02
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOPEN AND ACCESSORIES
CIMEX BIOTECH, LLC. 510(k) NO: K012214(TRADITIONAL)
ATTN: MICHAEL HAAS PHONE NO : 504-871-0802
72385 INDUSTRY PARK SE DECISION MADE: 26-APR-02
COVINGTON, LA 70435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC C
CIRCON VIDEO 510(k) NO: K012758(TRADITIONAL)
ATTN: WAYNE STERNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 09-APR-02
SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARMEDICAL/RADI FEMOSTOP COMPRESSION SYSTEM, MODEL 017500
CLEAR MEDICAL, INC. 510(k) NO: K012604(TRADITIONAL)
ATTN: RICHARD RADFORD PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 19-APR-02
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPEX SPORT
COMPEX S.A. 510(k) NO: K011880(TRADITIONAL)
ATTN: ANSIS M HELMANIS PHONE NO : 202-457-0300
1225 EYE STREET, N.W. SE DECISION MADE: 17-APR-02
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONM
CONMED CORP. 510(k) NO: K020135(TRADITIONAL)
ATTN: CHARLES M HART PHONE NO : 303-699-7600
14603 FREMONT AVE. SE DECISION MADE: 12-APR-02
CENTENNIAL, CO 80112 510(k) STATEMENT
DEVICE: CONMED SYSTEM 5000 ESU
CONMED CORP. 510(k) NO: K020186(TRADITIONAL)
ATTN: CHARLES M (MIKE) HART PHONE NO : 303-699-7600
14603 FREMONT AVE. SE DECISION MADE: 12-APR-02
CENTENNIAL, CO 80112 510(k) STATEMENT
DEVICE: STRATASIS SLING KIT
COOK BIOTECH, INC. 510(k) NO: K020654(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 09-APR-02
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPONADE UTERINE BALLOON CATHETER SET
COOK OB/GYN 510(k) NO: K013597(TRADITIONAL)
ATTN: CINDY RUMPLE PHONE NO : 812-829-6500
1100 W. MORGAN STREET SE DECISION MADE: 17-APR-02
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
COOK VASCULAR, INC. 510(k) NO: K010128(TRADITIONAL)
ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621
P.O. BOX 529 SE DECISION MADE: 25-APR-02
LEECHBURG, PA 15656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
COOK, INC. 510(k) NO: K013865(SPECIAL)
ATTN: LISA HOPKINS PHONE NO : 800-346-2686
925 SOUTH CURRY PIKE SE DECISION MADE: 22-APR-02
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS F
COOPERVISION, INC. 510(k) NO: K020392(TRADITIONAL)
ATTN: BONNIE TSYMBAL PHONE NO : 585-264-3210
711 NORTH RD. SE DECISION MADE: 26-APR-02
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
CORDIS CORP. 510(k) NO: K020809(SPECIAL)
ATTN: DONNA MARSHALL PHONE NO : 908-412-3844
7 POWDER HORN DRIVE SE DECISION MADE: 12-APR-02
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNE CELL FUNCTION ASSAY
CYLEX, INC. 510(k) NO: K013169(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 02-APR-02
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH AMPIC
DADE BEHRING, , INC. 510(k) NO: K020319(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 17-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH PIPER
DADE BEHRING, , INC. 510(k) NO: K020397(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 22-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTR
DADE MICROSCAN, INC. 510(k) NO: K020506(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
1584 ENTERPRISE BLVD. SE DECISION MADE: 17-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
DADE MICROSCAN, INC. 510(k) NO: K020556(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 26-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
DADE MICROSCAN, INC. 510(k) NO: K020626(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 26-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM
DADE MICROSCAN, INC. 510(k) NO: K020686(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 30-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
DADE MICROSCAN, INC. 510(k) NO: K020691(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 30-APR-02
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUWAVE
DAN MED, INC. 510(k) NO: K013210(TRADITIONAL)
ATTN: THOMAS SANDGAARD PHONE NO : 800-495-6670
4 WEST DRY CREEK CIRCLE, SE DECISION MADE: 04-APR-02
SUITE 260 510(k) STATEMENT
DENVER, CO 80120
DEVICE: DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB;
DATASCOPE CORP. 510(k) NO: K020257(TRADITIONAL)
ATTN: JOANN WOLF PHONE NO : 973-244-6123
15 LAW DR. SE DECISION MADE: 24-APR-02
FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAORAL CAMERA ME-15
DENT CORP. RESEARCH & DEVELOPMENT 510(k) NO: K020206(TRADITIONAL)
ATTN: DAVID ABELDA PHONE NO : 914-682-6600
7-11 S. BROADWAY SE DECISION MADE: 11-APR-02
WHITE PLAINS, NY 10601 510(k) STATEMENT
DEVICE: DEPILASE TWIN YAG LASER SYSTEM
DEPILASE GROUP LTD. 510(k) NO: K020697(ABBREVIATED)
ATTN: MARIO RUSSO PHONE NO : 442 077 121675
ONE CANADA SQUARE SE DECISION MADE: 12-APR-02
CANARY WHARF 510(k) SUMMARY AVAILABLE FROM FDA
LONDON, UNITED KINGDOM E14 5DY THIRD PARTY REVIEW
DEVICE: DIASOL-BICARB
DIASOL, INC. 510(k) NO: K020230(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 23-APR-02
NORTH HOLLYWOOD, CA 91605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
DIDECO S.P.A. 510(k) NO: K020997(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 04-APR-02
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHIN ELECTRODE
DYMEDIX, INC. 510(k) NO: K020468(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 16-APR-02
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "DELTA 2000" SERIES EXTRACORPOREAL LITHOTRIPTER
E.S.W.L. PRODUCTS, INC. 510(k) NO: K013471(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 29-APR-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATIC CRANIOPLASTY ORTHOSIS
EASTERN CRANIAL AFFILIATES 510(k) NO: K020448(TRADITIONAL)
ATTN: JOSEPH TERPENNING PHONE NO : 703-516-4340
2525 NORTH TENTH STREET # 804 SE DECISION MADE: 12-APR-02
ARLINGTON, VA 22201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI OMEGA21 SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K020681(SPECIAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 03-APR-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCH
ECHOTECH 3D IMAGING SYSTEMS, INC. 510(k) NO: K013088(TRADITIONAL)
ATTN: KEVIN MORNINGSTAR PHONE NO : 303-697-8198
PO BOX 218 SE DECISION MADE: 04-APR-02
INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
ECI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K020918(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 902 543 6665
2 COOK RD. SE DECISION MADE: 19-APR-02
BRIDGEWATER, NOVA SCOTIA, CANADA B510(k) STATEMENT
DEVICE: AXILLARY ACCESS ARTERIAL CANNULA
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K002578(TRADITIONAL)
ATTN: KAREN JONES PHONE NO : 801-565-6231
6864 SOUTH 300 WEST SE DECISION MADE: 11-APR-02
MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K020864(SPECIAL)
ATTN: SUSAN REYNOLDS PHONE NO : 949-250-2482
ONE EDWARDS WAY SE DECISION MADE: 17-APR-02
IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFILM WORKSTATION WITH MODULES
EFILM MEDICAL, INC. 510(k) NO: K020995(TRADITIONAL)
ATTN: JOSEPH A THOMAS PHONE NO : 416 204 9664 X291
500 UNIVERSITY AVE., SUITE 300 SE DECISION MADE: 12-APR-02
TORONTO, ONTARIO, CANADA M5G 1V7 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
ELAN DIAGNOSTICS 510(k) NO: K020575(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 12-APR-02
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS ELECTROSTATIC FLITER AND HME COMBINATION
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K013122(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 19-APR-02
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRONOMER PLUS SYSTEM
EP TECHNOLOGIES, INC. 510(k) NO: K013349(ABBREVIATED)
ATTN: ANDREA L RUTH PHONE NO : 408-895-3500
2710 ORCHARD PKWY. SE DECISION MADE: 09-APR-02
SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
ETHICON ENDO-SURGERY, INC. 510(k) NO: K020276(TRADITIONAL)
ATTN: GEORGE C ABERNATHY PHONE NO : 513-337-3179
4545 CREEK RD. SE DECISION MADE: 12-APR-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVANS SUB-Q, MODEL MC4206
EVANS MEDICAL, INC. 510(k) NO: K020530(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 29-APR-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRIALOC DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K013067(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 09-APR-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GARAVENTA SUPER-TRAC TRE-52
GARAVENTA ACCESSIBILITY 510(k) NO: K020933(SPECIAL)
ATTN: NORM COOPER PHONE NO : 800-663-6556
BOX 1769 SE DECISION MADE: 04-APR-02
BLAIN, WA 98231-1769 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC FUJI ORTHO BAND PASTE PAK
GC AMERICA, INC. 510(k) NO: K020578(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 26-APR-02
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
GE MEDICAL SYSTEMS 510(k) NO: K020929(TRADITIONAL)
ATTN: PHONE NO :
283 RUE DE LA MINIERE SE DECISION MADE: 03-APR-02
BP 34 510(k) SUMMARY AVAILABLE FROM FDA
BUC CEDEX, FRANCE 78533 THIRD PARTY REVIEW
DEVICE: OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
GE OEC MEDICAL SYSTEMS 510(k) NO: K021049(TRADITIONAL)
ATTN: BILL GISLASON PHONE NO : 801-536-4520
384 WRIGHT BROTHERS DR. SE DECISION MADE: 17-APR-02
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIVID 3 EXPERT; GE VIVID 3 PRO
GENERAL ELECTRIC CO. 510(k) NO: K020789(TRADITIONAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 04-APR-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANG
GISH BIOMEDICAL, INC. 510(k) NO: K020106(TRADITIONAL)
ATTN: JAMES H KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 10-APR-02
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL GT980201 ELECTRONIC THERMOMETER
GLOBAL TREASURE LTD. 510(k) NO: K021028(TRADITIONAL)
ATTN: BEN MA PHONE NO : 852 145 41883
BLOCK2, 5/F,. ROOM 8 SE DECISION MADE: 08-APR-02
NAN FUNG IND. CITY 510(k) SUMMARY AVAILABLE FROM FDA
18 TIN HAU ROAD, TUEN MUN N.T., HOTHIRD PARTY REVIEW
DEVICE: MODEL GT010706 ELECTRONIC THERMOMETER
GLOBAL TREASURE LTD. 510(k) NO: K021052(TRADITIONAL)
ATTN: PHONE NO :
BLOCK2, 5/F,. ROOM 8 SE DECISION MADE: 09-APR-02
NAN FUNG IND. CITY 510(k) SUMMARY AVAILABLE FROM FDA
18 TIN HAU ROAD, TUEN MUN N.T., HOTHIRD PARTY REVIEW
DEVICE: GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LAB
GREAT GLOVE SDN BHD 510(k) NO: K020363(TRADITIONAL)
ATTN: NOOR AKILAH PHONE NO : 603 325 00646
24, JALAN RAJA MOKHTAR DUA SE DECISION MADE: 10-APR-02
KAPAR, SELANGOR D.E., MALAYSIA 422510(k) STATEMENT
DEVICE: GYRUS ENT SOMNOPLASTY GENERATOR
GYRUS ENT L.L.C. 510(k) NO: K020067(TRADITIONAL)
ATTN: JEFFREY W COBB PHONE NO : 901-373-2673
2925 APPLING RD SE DECISION MADE: 04-APR-02
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERRALNYL
H & A CONSULTANTS 510(k) NO: K020146(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414
2584 SADDLEWOOD LANE SE DECISION MADE: 15-APR-02
PALM HARBOR, FL 34685 510(k) STATEMENT
DEVICE: SERRALSILK
H & A CONSULTANTS 510(k) NO: K020901(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 727-773-0414
2584 SADDLEWOOD LANE SE DECISION MADE: 26-APR-02
PALM HARBOR, FL 34685 510(k) STATEMENT
DEVICE: BIOSUC
HAKKO MEDICAL CO., LTD. 510(k) NO: K013108(TRADITIONAL)
ATTN: MSHIRO KITAGAWA PHONE NO : 81 3 4648500
7-9 KAMIMEGURO 1-CHOME SE DECISION MADE: 04-APR-02
MEGURO-KU, TOKYO, JAPAN 153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #L
HAKKO SHOJI CO., LTD. 510(k) NO: K020307(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK ROAD SE DECISION MADE: 26-APR-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2
HARVEST TECHNOLOGIES, CORP. 510(k) NO: K020252(TRADITIONAL)
ATTN: JOHN D BONASERA PHONE NO : 508-732-7530
40 GRISSOM RD, SUITE 100 SE DECISION MADE: 05-APR-02
PLYMOUTH, MA 02360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSENSUS ACETABLAR SHELL, TI COATED
HAYES MEDICAL, INC. 510(k) NO: K020153(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 15-APR-02
EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT
DEVICE: HL168F
HEALTH & LIFE CO., LTD. 510(k) NO: K020766(SPECIAL)
ATTN: SUSAN CHEN PHONE NO : 886 232 349600
6F,NO. 407, CHUNG SHAN RD. SE DECISION MADE: 05-APR-02
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: HISONIC-TRD TINNITUS RELIEF DEVICE
HEARING INNOVATIONS, INC. 510(k) NO: K013253(TRADITIONAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5910
COLUMBIA SQUARE SE DECISION MADE: 05-APR-02
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
HEMOCUE, INC. 510(k) NO: K020935(SPECIAL)
ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 03-APR-02
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
HOMMED LLC. 510(k) NO: K014025(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DRIVE SE DECISION MADE: 09-APR-02
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMMED CENTRAL STATION
HOMMED LLC. 510(k) NO: K020184(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DRIVE SE DECISION MADE: 22-APR-02
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16"
HOSUK CO., LTD. 510(k) NO: K021197(SPECIAL)
ATTN: CAROLE STAMP PHONE NO : 952-946-8080
5353 WAYZATA BLVD., STE 505 SE DECISION MADE: 26-APR-02
MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
HOVEROUND CORP. 510(k) NO: K021136(SPECIAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 19-APR-02
SARASOTA, FL 34243 510(k) STATEMENT
DEVICE: 2 PIECE MODULAR HIP STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K013106(TRADITIONAL)
ATTN: WILLIAMR J CYMBALUK PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 03-APR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LONG LENGTH GAMMA NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020773(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 04-APR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVON PATELLAR COMPONENT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020841(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 11-APR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER EON PLUS FEMORAL STEMS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K020989(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379
59 ROUTE 17 SE DECISION MADE: 26-APR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 FEMORAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K021026(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 25-APR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 TIBIAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K021027(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 25-APR-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FETAL ASSIST
HUNTLEIGH DIAGNOSTICS LTD. 510(k) NO: K020390(TRADITIONAL)
ATTN: AUDREY WITKO PHONE NO : 800-223-1218
40 CHRISTOPHER WAY SE DECISION MADE: 19-APR-02
EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
HYDROCISION, INC. 510(k) NO: K020688(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
7 TIFFANY TRAIL SE DECISION MADE: 03-APR-02
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 53
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012417(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 08-APR-02
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012650(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012651(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012654(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012657(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 12-APR-02
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012956(TRADITIONAL)
ATTN: GEOFF M FATZINGER PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 11-APR-02
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYALLERGYTEST SYSTEM
IMMUNETECH CORPORATION 510(k) NO: K020387(TRADITIONAL)
ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483
P.O. BOX 9433 SE DECISION MADE: 17-APR-02
17394 VIA DEL BRAVO 510(k) SUMMARY AVAILABLE FROM FDA
RANCHO SANTA FE, CA 92067
DEVICE: BIOCELLECT -PERIO
IMTEC CORP. 510(k) NO: K020396(TRADITIONAL)
ATTN: M.K. PATTERSON PHONE NO : 405-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 10-APR-02
ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE CCP ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K020414(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 29-APR-02
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE-STEER GUIDE WIRE SYSTEM
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K011986(TRADITIONAL)
ATTN: PAMELA L MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 03-APR-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: 4 ALL (DW286A)
IVOCLAR VIVADENT, INC. 510(k) NO: K020253(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 17-APR-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: CHEMISTRY CALIBRATOR
JAS DIAGNOSTIC, INC. 510(k) NO: K020454(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 08-APR-02
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: BOND-3 ADHESIVE
JENERIC/PENTRON, INC. 510(k) NO: K020499(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-APR-02
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FOX PTA CATHETER
JOMED AG 510(k) NO: K020854(SPECIAL)
ATTN: CHRISTINA KICHULA PHONE NO : 301-998-6151
1700 ROCKVILLE PIKE, SUITE 400 SE DECISION MADE: 11-APR-02
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
JOSTRA AG 510(k) NO: K020515(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA ROAD SE DECISION MADE: 24-APR-02
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA FIBERSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K011793(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 17-APR-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XR PRIMER 2
KERR DENTAL MATERIALS CENTER 510(k) NO: K020303(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 19-APR-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L.A.M. IPM WOUND GEL
L.A.M. PHARMACEUTICAL, CORP. 510(k) NO: K020325(TRADITIONAL)
ATTN: CLAWSON BOWMAN PHONE NO : 707-793-2600
1330A REDWOOD WAY SE DECISION MADE: 15-APR-02
PETALUMA, CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K020769(TRADITIONAL)
ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360
2391 ZANKER RD., SUITE 340 SE DECISION MADE: 03-APR-02
SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESECTION ABLATOR
LINVATEC CORP. 510(k) NO: K013369(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 04-APR-02
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
MACHNET BV 510(k) NO: K020289(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 24-APR-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTR
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K021155(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 29-APR-02
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MID LABS AUTONOMOUS VIT ENHANCER (AVE)
MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K020911(TRADITIONAL)
ATTN: LINDA M UPTON PHONE NO : 510-357-3952
14477 CATALINA ST. SE DECISION MADE: 29-APR-02
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K020147(TRADITIONAL)
ATTN: LUCY TAN PHONE NO : 763-391-9000
7611 NORTHLAND DR. N SE DECISION MADE: 03-APR-02
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
MEDTRONIC, INC. 510(k) NO: K013517(TRADITIONAL)
ATTN: KRISTY K MOLLNER PHONE NO : 763-514-4189
7000 CENTRAL AVE. N.E. SE DECISION MADE: 25-APR-02
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K021077(TRADITIONAL)
ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669
11506 SOUTH STATE ST. SE DECISION MADE: 17-APR-02
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HDR MIAMI APPLICATOR
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K020176(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 914-667-3999
521 HOMESTEAD AVE. SE DECISION MADE: 08-APR-02
MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRULINE REINFORCED VALVED INFUSION CATHETER
MICRO THERAPEUTICS, INC. 510(k) NO: K021139(SPECIAL)
ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 17-APR-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
MILLIPORE CORP. 510(k) NO: K013988(SPECIAL)
ATTN: THOMAS BORROWS PHONE NO : 781-533-2622
80 ASHBY RD. SE DECISION MADE: 04-APR-02
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: FUSION 7D
MIRADA SOLUTIONS LTD 510(k) NO: K020546(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 26-APR-02
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATING MATERIAL, CAL-PAK, BUFFERS
MISSION DIAGNOSTICS 510(k) NO: K020894(TRADITIONAL)
ATTN: LINDA STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 29-APR-02
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
MONOBIND 510(k) NO: K020548(TRADITIONAL)
ATTN: JAY SINGH PHONE NO : 949-642-4830
729 WEST 16TH ST., C-4 SE DECISION MADE: 05-APR-02
COSTA MESA, CA 92627 510(k) STATEMENT
DEVICE: SURGIC IV IMPLANT CONTROL UNIT
NAKANISHI, INC. 510(k) NO: K020327(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 011 812 89643422
700 SHIMOHINATA SE DECISION MADE: 08-APR-02
KANUMA-SHI, TOCHIGI-KEN, JAPAN 322510(k) STATEMENT
DEVICE: WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K020604(SPECIAL)
ATTN: GINA TO PHONE NO : 925-463-4427
4280 HACIENDA DR. SE DECISION MADE: 23-APR-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT-C3000 SPIRAL CT SCANNER SYSTEM
NEUSOFT DIGITAL MEDICAL SYSTEM CO.510(k) NO: K020913(TRADITIONAL)
ATTN: WANG ZHIQIANG PHONE NO : 86 24 23783000
NO.3-11, WENHUA ROAD SE DECISION MADE: 03-APR-02
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: SNAP EEG MONITOR
NICOLET BIOMEDICAL, INC. 510(k) NO: K020218(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 22-APR-02
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICOLET ELECTROCAUTERY DETECTOR
NICOLET BIOMEDICAL, INC. 510(k) NO: K020955(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 17-APR-02
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSALAB APM
NICOLET VASCULAR, INC. 510(k) NO: K013281(ABBREVIATED)
ATTN: DAVID W WAGNER PHONE NO : 303-431-9400
6355 JOYCE DR. SE DECISION MADE: 18-APR-02
GOLDEN, CO 80403 510(k) STATEMENT
DEVICE: NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
NIDEK, INC. 510(k) NO: K014274(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 17-APR-02
LAKE FOREST, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE THERAPY SYSTEM
NXSTAGE MEDICAL, INC. 510(k) NO: K020858(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION STREET SE DECISION MADE: 17-APR-02
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843
DEVICE: OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K020690(TRADITIONAL)
ATTN: CHARLES R VERMETTE PHONE NO : 510-724-0384
629 TENNENT AVE. SE DECISION MADE: 26-APR-02
PINOLE, CA 94564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K020601(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010
P.O. BOX 248 SE DECISION MADE: 24-APR-02
YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS
OHIO MEDICAL INSTRUMENT CO., INC. 510(k) NO: K013428(TRADITIONAL)
ATTN: DONALD A LINCOLN PHONE NO : 508-384-2506
10 OAK POINT SE DECISION MADE: 04-APR-02
WRENTHAM, MA 02093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
ORASURE TECHNOLOGIES, INC. 510(k) NO: K013882(TRADITIONAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVE SE DECISION MADE: 17-APR-02
BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPLINK TEST SYSTEM
ORASURE TECHNOLOGIES, INC. 510(k) NO: K020371(TRADITIONAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVE SE DECISION MADE: 03-APR-02
BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVISION ANTERIOR CERVICAL PLATE SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K020649(TRADITIONAL)
ATTN: CAROL FREASIER PHONE NO : 801-553-9991
12187 S. BUSINESS PARK DR. SE DECISION MADE: 05-APR-02
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAG
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K020662(TRADITIONAL)
ATTN: ANN M QUINN PHONE NO : 716-453-4041
100 INDIGO CREEK DRIVE SE DECISION MADE: 12-APR-02
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
ORTHOPAEDIC INNOVATIONS, INC. 510(k) NO: K020145(TRADITIONAL)
ATTN: GREGORY M MERCURI PHONE NO : 763-591-0001
6188 OLSON MEMORIAL HWY. SE DECISION MADE: 15-APR-02
GOLDEN VALLEY, MN 55422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXOID PBP2 1 LATEX AGGLUTINATION TEST
OXOID, LTD. 510(k) NO: K011710(TRADITIONAL)
ATTN: A. HOLLINGSWORTH PHONE NO : 012 568 41144
WADE RD. SE DECISION MADE: 02-APR-02
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT
DEVICE: DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
PACIFIC CONSOLIDATED INDUSTRIES LL510(k) NO: K020330(ABBREVIATED)
ATTN: LEE W SMITH PHONE NO : 714-979-9200
3430 WEST CARRIAGE DRIVE SE DECISION MADE: 12-APR-02
SANTA ANA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVS BASIC 2; EPIC 2
PARAGON VISION SCIENCES 510(k) NO: K013310(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 25-APR-02
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATTON TRIPOL
PATTON MEDICAL CORP. 510(k) NO: K012279(TRADITIONAL)
ATTN: MICHAEL T PATTON PHONE NO : 512-329-0469
1000 WESTBANK DRIVE SE DECISION MADE: 30-APR-02
SUITE 5A200 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: SONATA MICRO HYBRID COMPOSITE
PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K020555(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-APR-02
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K020708(ABBREVIATED)
ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319
3000 MINUTEMAN RD. SE DECISION MADE: 25-APR-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 50S TRINGA ULTRASOUND IMAGING SYSTEM
PIE MEDICAL 510(k) NO: K020112(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
8000 CASTLEWAY DRIVE SE DECISION MADE: 19-APR-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE LATEX CONDOM WITH RIBBED SURFACE
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K020272(ABBREVIATED)
ATTN: KOI-YONG LIM PHONE NO : 603 326 40784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 26-APR-02
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR DARUL EHSAN, MALAYSIA 45800
DEVICE: POLYMEDCO HBA1C TEST
POLYMEDCO, INC. 510(k) NO: K020532(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
510 FURNACE DOCK RD. SE DECISION MADE: 24-APR-02
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: VT-1
POS-T-VAC, INC. 510(k) NO: K020154(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 800-279-7434
1701 NORTH 14TH AVE. SE DECISION MADE: 04-APR-02
DODGE CITY, KS 67801 510(k) STATEMENT
DEVICE: SUPPORT SLEEVE
POS-T-VAC, INC. 510(k) NO: K020258(TRADITIONAL)
ATTN: DENNIS L BELL PHONE NO : 800-279-7434
1701 NORTH 14TH AVE. SE DECISION MADE: 04-APR-02
DODGE CITY, KS 67801 510(k) STATEMENT
DEVICE: SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED RE
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K020343(SPECIAL)
ATTN: LAURENCE A POTTER PHONE NO : 215-862-4450
110 UNION SQUARE DR. SE DECISION MADE: 10-APR-02
NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAG
PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K021076(SPECIAL)
ATTN: BRENDA LEE PHONE NO : 780 497 7600 X225
10707-100TH AVE., SUITE 300 SE DECISION MADE: 16-APR-02
EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) STATEMENT
DEVICE: MITYVAC MERLIN, MODEL 10027
PRISM ENTERPRISES, INC. 510(k) NO: K020447(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET N.W. SE DECISION MADE: 12-APR-02
WASHINGTON, DC 20004-5600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
PRO-TECH SERVICES, INC. 510(k) NO: K013905(SPECIAL)
ATTN: NEIL SHELLER PHONE NO : 425-481-5452
4338 HARBOUR POINTE BLVD. S.W. SE DECISION MADE: 22-APR-02
MUKILTEO, WA 98275 510(k) STATEMENT
DEVICE: DENTITION INTEGRATING MATERIAL
PULPDENT CORPORATION 510(k) NO: K020287(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 12-APR-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT GLAZE
PULPDENT CORPORATION 510(k) NO: K020432(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 17-APR-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT POST CEMENT
PULPDENT CORPORATION 510(k) NO: K020481(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 17-APR-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RE-USABLE STERILIZATION POUCH / BAG
QUALITY PRODUCTS OF MONTANA 510(k) NO: K013715(TRADITIONAL)
ATTN: LARRY LARSON PHONE NO : 406-542-0950
100 NORTH JOHNSON #7 SE DECISION MADE: 01-APR-02
MISSOULA, MT 59801 510(k) STATEMENT
DEVICE: VIRIDIS DERMA LASER
QUANTEL MEDICAL 510(k) NO: K020071(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 05-APR-02
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHOS LASER
QUANTEL MEDICAL 510(k) NO: K020072(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 09-APR-02
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPI SKIN OR AIR TEMPERATURE PROBE
REPLACEMENT PARTS INDUSTRIES, INC.510(k) NO: K020219(TRADITIONAL)
ATTN: IRA LAPIDES PHONE NO : 818-882-8611
P.O. BOX 5019 SE DECISION MADE: 12-APR-02
CHATSWORTH, CA 91313-5019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
RHIGENE, INC. 510(k) NO: K011068(TRADITIONAL)
ATTN: DAVID KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 11-APR-02
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: CLEARVIEW WRIST FIXATOR
RIGID FX ORTHOPEDICS, INCORPORATED510(k) NO: K020311(TRADITIONAL)
ATTN: MARK ESTRADA PHONE NO : 512-443-7770
3601 S. CONGRESS, BLDG B #300 SE DECISION MADE: 29-APR-02
AUSTIN, TX 78704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ONLINE THEOPHYLLINE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020740(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 16-APR-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NETLINK/NETSCAN
ROZINN ELECTRONICS, INC. 510(k) NO: K020213(TRADITIONAL)
ATTN: MARK ROSOFF PHONE NO : 718-386-5526
71-22 MYRTLE AVE. SE DECISION MADE: 05-APR-02
GLENDALE, NY 11385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUBICOR BREAST BIOPSY DEVICE
RUBICOR MEDICAL, INC. 510(k) NO: K020047(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVENUE SE DECISION MADE: 05-APR-02
SAN CAROLS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
SCANDIA MANUFACTURING LTD. 510(k) NO: K003916(TRADITIONAL)
ATTN: RONALD E BERGLUND PHONE NO : 612-888-8282
9220 JAMES AVENUE SOUTH SE DECISION MADE: 15-APR-02
BLOOMINGTON, MN 55431 510(k) STATEMENT
DEVICE: MONITORING SYSTEM,MODEL ARGUS PB-1000
SCHILLER AG 510(k) NO: K012226(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 041 766 4252
ALTGASSE 68 SE DECISION MADE: 08-APR-02
BAAR, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WH
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K020868(TRADITIONAL)
ATTN: CHUN CHOOI FONG PHONE NO : 605 322 3200
LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 22-APR-02
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
SMITH & NEPHEW, INC. 510(k) NO: K020947(SPECIAL)
ATTN: DEBORAH CONNERS PHONE NO : 978-749-1495
160 DASCOMB RD. SE DECISION MADE: 17-APR-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
SPIRE BIOMEDICAL INC 510(k) NO: K013160(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6000
ONE PATRIOTS PARK SE DECISION MADE: 11-APR-02
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPR
SSL AMERICA'S, INC. 510(k) NO: K020308(TRADITIONAL)
ATTN: JOYCE NING PHONE NO : 770-582-2152
3585 ENGINEERING DR.,SUITE 200 SE DECISION MADE: 03-APR-02
P.O. BOX 926090 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092-9214
DEVICE: SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
ST. JUDE MEDICAL 510(k) NO: K020890(SPECIAL)
ATTN: KIRK S HONOUR PHONE NO : 952-352-9737
14901 DEVEAU PL. SE DECISION MADE: 17-APR-02
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED GUIDEWIRES
STERILMED, INC. 510(k) NO: K012556(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 29-APR-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY SIMPLEX SOFT INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K020629(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 01-APR-02
LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT
DEVICE: SIMPLICITY EASY SOFT INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K020912(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 10-APR-02
LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION
STERLING MEDIVATIONS, INC. 510(k) NO: K020990(SPECIAL)
ATTN: JOEL DOUGLAS PHONE NO : 408-297-9474
25285 LA LOMA DR. SE DECISION MADE: 10-APR-02
LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT
DEVICE: SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJEC
STERLING MEDIVATIONS, INC. 510(k) NO: K021005(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-814-4083
25285 LA LOMA DR. SE DECISION MADE: 25-APR-02
LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT
DEVICE: APOLLO, MODEL 1124525
STERNGOLD 510(k) NO: K020949(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 04-APR-02
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
STETHOGRAPHICS, INC. 510(k) NO: K012387(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 713-723-4080
11874 S. EVELYN CIRCLE SE DECISION MADE: 23-APR-02
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAL-CHEX CD PLUS
STRECK LABORATORIES, INC. 510(k) NO: K020469(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-537-5312
7002 SOUTH 109TH ST. SE DECISION MADE: 04-APR-02
LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANNULOFLO SYSTEM, MITRAL MODEL AR700
SULZER CARBOMEDICS, INC. 510(k) NO: K021051(SPECIAL)
ATTN: TEFFANY HANKINSON PHONE NO : 512-435-3202
1300 EAST ANDERSON LN. SE DECISION MADE: 23-APR-02
AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRASTENT LD (LARGE DIAMETER) STENT
SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K020528(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 651-697-4815
651 CAMPUS DR. SE DECISION MADE: 16-APR-02
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K014089(TRADITIONAL)
ATTN: MING SUN PHONE NO : 856-401-1080
604 VPR CENTER SE DECISION MADE: 25-APR-02
1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012
DEVICE: INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERN
SURGI-VISION, INC. 510(k) NO: K020495(TRADITIONAL)
ATTN: NANCY E TAYLOR PHONE NO : 301-527-2000
20 FIRSTFIELD RD. SUITE 200 SE DECISION MADE: 23-APR-02
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X
SUTURA, INC. 510(k) NO: K020940(SPECIAL)
ATTN: JAMES BONDS PHONE NO : 714-437-9801
17080 NEWHOPE ST. SE DECISION MADE: 17-APR-02
FOUNTAIN VALLEY, CA 92708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
SYNTERMED, INC. 510(k) NO: K020300(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
245 OWENS DRIVE SE DECISION MADE: 23-APR-02
ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES VERTEBRAL SPACER TI
SYNTHES (USA) 510(k) NO: K020152(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 16-APR-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES TRANSLATING MAXILLARY DISTRACTOR
SYNTHES (USA) 510(k) NO: K020505(TRADITIONAL)
ATTN: MATTHEW H HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 23-APR-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES DUAL-OPENING USS
SYNTHES (USA) 510(k) NO: K020517(SPECIAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 15-APR-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
SYNTHES SPINE 510(k) NO: K020244(TRADITIONAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-647-9700
1380 ENTERPRISE DRIVE SE DECISION MADE: 22-APR-02
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL
SYSMEX CORPORATION OF AMERICA 510(k) NO: K020496(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-726-3675
6699 WILDLIFE WAY SE DECISION MADE: 12-APR-02
LONG GROVE, IL 60047-9596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIIS#1 TISSUE SUSPENSION SYSTEM
TAG MEDICAL PRODUCTS 510(k) NO: K020705(TRADITIONAL)
ATTN: DAN MOOR PHONE NO : 011 972 49858400
SE DECISION MADE: 26-APR-02
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
TECHNOLOGY DELIVERY SYSTEMS, INC. 510(k) NO: K013300(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, STE C-100 SE DECISION MADE: 16-APR-02
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUEMEND SOFT TISSUE REPAIR MATRIX
TEI BIOSCIENCES INC. 510(k) NO: K020455(ABBREVIATED)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS STREET SE DECISION MADE: 03-APR-02
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K020998(SPECIAL)
ATTN: GARRY COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 04-APR-02
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
THE KENDALL COMPANY 510(k) NO: K020089(TRADITIONAL)
ATTN: REGINA YEH PHONE NO : 508-261-8404
15 HAMPSHIRE ST. SE DECISION MADE: 10-APR-02
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AL-2000 COMBINED BIOMETER AND PACHYMETER
TOMEY CORP. 510(k) NO: K012803(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 08-APR-02
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UD-1000 ULTRASONIC A/B SCANNER
TOMEY CORP. USA 510(k) NO: K020151(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 10-APR-02
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSPOINT TRANSACCESS CATHETER
TRANS VASCULAR INCORPORATED 510(k) NO: K013363(TRADITIONAL)
ATTN: STEVE JWANOUSKOS PHONE NO : 650-473-4500
1505-D ADAMS DRIVE SE DECISION MADE: 02-APR-02
MENLO PARK, CA 94925 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
U-SYSTEMS, INC. 510(k) NO: K013848(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 08-APR-02
LOS ALTOS,, CA 94204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRAL RADIUS 90-D RODDING SYSTEM
UNITED STATES SURGICAL, A DIVISION510(k) NO: K020134(TRADITIONAL)
ATTN: JENNIFER SCHUCK PHONE NO : 203-845-4512
150 GLOVER AVE. SE DECISION MADE: 15-APR-02
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAV COMBI-2
VIBRANT HEALTH 510(k) NO: K020565(TRADITIONAL)
ATTN: STEPHEN EMOND PHONE NO : 450 526 1295
150 DES GRANDS COTEAUX SE DECISION MADE: 30-APR-02
BEOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT
DEVICE: AKUPORT M-2
VIBRANT HEALTH 510(k) NO: K020568(TRADITIONAL)
ATTN: STEPHEN EMOND PHONE NO : 450 526 1295
150 DES GRANDS COTEAUX SE DECISION MADE: 30-APR-02
BEOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT
DEVICE: EAV KINDLING 2000S GSR DEVICE
VIRBRANT HEALTH 510(k) NO: K020564(TRADITIONAL)
ATTN: STEPHEN EMOND PHONE NO : 450 526 1295
150 DES GRANDS COTEAUX SE DECISION MADE: 30-APR-02
BELOEIL, QUEBEC, CANADA J3G 2C9 510(k) STATEMENT
DEVICE: LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
VIVOMETRICS, INC. 510(k) NO: K011903(TRADITIONAL)
ATTN: KEITH GILROY PHONE NO : 805-667-2225
121 NORTH FIR STREET SE DECISION MADE: 12-APR-02
SUITE E 510(k) SUMMARY AVAILABLE FROM FDA
VENTURA, CA 93001
DEVICE: DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
WELL-LIFE HEALTHCARE, INC. 510(k) NO: K020314(TRADITIONAL)
ATTN: TONY C.S. CHANG PHONE NO : 886 422 972787
NO. 5 ALLEY 5 LANE CHENG HSING SE DECISION MADE: 30-APR-02
CHUNG CHING RD., PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN)
DEVICE: DIGI-PRO TENS MODEL WL-2203 AND WL-2205
WELL-LIFE HEALTHCARE, INC. 510(k) NO: K021359(TRADITIONAL)
ATTN: TONY C.S. CHANG PHONE NO : 886 422 972476
NO. 5 ALLEY 5 LANE CHENG HSING SE DECISION MADE: 30-APR-02
CHUNG CHING RD., PEI TUN DIST. 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN)
DEVICE: AGC SPEZIALLEGIERUNG
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K020347(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 24-APR-02
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI HI-FLO PNEU, WISAP #7080
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K011510(TRADITIONAL)
ATTN: HORST SEMM PHONE NO : 490 810 489080
RUDOLF-DIESEL-RING 20 SE DECISION MADE: 02-APR-02
SAUERLACH, GERMANY D-82054 510(k) STATEMENT
DEVICE: THERMOMETER MODELS ST8631
Z7 INTERNATIONAL 510(k) NO: K021048(TRADITIONAL)
ATTN: PHIL ZULUETA PHONE NO : 661-269-1006
34138 COURTNEY TERRACE SE DECISION MADE: 22-APR-02
ACTON, CA 93510 510(k) STATEMENT
DEVICE: MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYS
ZEUS SCIENTIFIC, INC. 510(k) NO: K021103(SPECIAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
P.O. BOX 38 SE DECISION MADE: 24-APR-02
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: ZOLL PAD WITH CPR AID
ZOLL MEDICAL CORP. 510(k) NO: K011541(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 800-242-9150
32 SECOND AVENUE SE DECISION MADE: 11-APR-02
BURLINGTON, MA 01803-4420 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 274
TOTAL WITH SUMMARIES 222
TOTAL WITH STATEMENTS 52
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