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510(k)s Final Decisions Rendered for September 2001 |
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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-SEP-2001 THROUGH 30-SEP-2001
DEVICE: RAPIDIA
3D MED CO., LTD. 510(k) NO: K012290(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 28-SEP-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANDPIECE SHEATH-MODEL #A910
AARON MEDICAL, INC. 510(k) NO: K011929(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727-384-2323
7100- 30TH AVENUE NORTH SE DECISION MADE: 18-SEP-01
ST. PETERSBURG, FL 33710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
ABBOTT LABORATORIES 510(k) NO: K012934(SPECIAL)
ATTN: JOHN DEAN PHONE NO : 408-567-3430
5440 PATRICK HENRY DR. SE DECISION MADE: 28-SEP-01
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUIMAGE SMARTGATE UPGRADE
ACCUIMAGE DIAGNOSTICS CORP. 510(k) NO: K012106(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 25-SEP-01
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP
ACON LABORATORIES, INC. 510(k) NO: K012300(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-SEP-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
ACRYMED, INC. 510(k) NO: K012116(SPECIAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830
12232 S.W. GARDEN PL. SE DECISION MADE: 12-SEP-01
PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SI
ACUSUPPLY, INC. 510(k) NO: K011242(TRADITIONAL)
ATTN: FERES DAGER PHONE NO : 305-932-9413
3801 NE 207TH STREET SE DECISION MADE: 11-SEP-01
AVENTURA, FL 33180 510(k) STATEMENT
DEVICE: ADVANCE MEDICAL DESIGNS FLUID POUCH
ADVANCE MEDICAL DESIGNS, INC. 510(k) NO: K012168(TRADITIONAL)
ATTN: BILL GILL PHONE NO : 770-422-3125
1241 ATLANTA INDUSTRIAL DR. SE DECISION MADE: 18-SEP-01
MARIETTA, GA 30066 510(k) STATEMENT
DEVICE: AOS MODULAR FEMORAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS 510(k) NO: K012190(TRADITIONAL)
ATTN: GARY SOHNGEN PHONE NO : 310-831-6787
333 WEST 6TH ST., SUITE 202 SE DECISION MADE: 24-SEP-01
SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMICRON NONABSORBABLE PET SURGICAL SUTURE
AESCULAP, INC. 510(k) NO: K012201(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 19-SEP-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AETMED IMAGE PROCESSING SOFTWARE
AETMED, S.P.A. 510(k) NO: K012093(TRADITIONAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 21-SEP-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LR 5200 FILM RECORDER
AGFA CORP. 510(k) NO: K012010(TRADITIONAL)
ATTN: T.WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PKWY,STE 625 SE DECISION MADE: 20-SEP-01
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADC COMPACT PLUS
AGFA-GEVAERT AG 510(k) NO: K013138(SPECIAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 28-SEP-01
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: 2010 PLUS HOLTER FOR WINDOWS
AGILENT TECHNOLOGIES 510(k) NO: K010949(TRADITIONAL)
ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941
1201 "B" N. RICE AVE SE DECISION MADE: 28-SEP-01
OXNARD, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K012149(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 24-SEP-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHABLE IMPERVIOUS GOWNS
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K012984(SPECIAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 24-SEP-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICLOT PROTEIN S, MODEL 843L
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K012386(TRADITIONAL)
ATTN: JOHN B BERRYMAN PHONE NO : 203-661-0000
222 RAILROAD AVE. SE DECISION MADE: 14-SEP-01
GREENWICH, CT 06830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS SOFT-TISSUE APPROXIMATION SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K012342(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6309
10700 BREN ROAD WEST SE DECISION MADE: 05-SEP-01
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX ETCHANT
APEX DENTAL MATERIALS, INC. 510(k) NO: K010849(TRADITIONAL)
ATTN: SCOTT LAMERAND PHONE NO : 847-490-1014
603 BERKLEY COURT SE DECISION MADE: 14-SEP-01
SCHUMBURG, IL 60194 510(k) STATEMENT
DEVICE: SURESTEP COCAINE (COC)II DRUG SCREEN TEST
APPLIED BIOTECH, INC. 510(k) NO: K012188(TRADITIONAL)
ATTN: DAVE D SMITH PHONE NO : 858-713-9614
10237 FLANDERS CT. SE DECISION MADE: 13-SEP-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: BANDVIEW SYSTEM
APPLIED SPECTRAL IMAGING, LTD. 510(k) NO: K012103(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 9 7718130
117 AHUZAH STREET SE DECISION MADE: 14-SEP-01
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUA WATER TREATMENT FOR HEMODIALYSIS
AQUA WATER TREATMENT, INC. 510(k) NO: K010592(TRADITIONAL)
ATTN: ANTHONY WEATHERS PHONE NO : 850-939-9055
8195 EAST BAY BLVD. SE DECISION MADE: 28-SEP-01
NAVARRE, FL 32566 510(k) STATEMENT
DEVICE: INTRA OPERATIVE RADIATION THERAPY
ARPLAY MEDICAL S.A. 510(k) NO: K004023(TRADITIONAL)
ATTN: RICHARD BORGI PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX SE DECISION MADE: 21-SEP-01
IZEURE, COTE D'OR, FRANCE 21110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROSCOPE, ARTES MEDICAL, USA
ARTES MEDICAL USA, INC. 510(k) NO: K003988(TRADITIONAL)
ATTN: WILLIAM KIRKPATRICK PHONE NO : 858-550-9999
4660 LA JOLLA VILLAGE DRIVE SE DECISION MADE: 06-SEP-01
CENTER 1, SUITE 825 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92122
DEVICE: ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
ARTSCAN MEDICAL INNOVATIONS 510(k) NO: K010303(TRADITIONAL)
ATTN: ROBERT ANTHONY PHONE NO : 330-666-6992
4804 OIN OAK ROAD SE DECISION MADE: 11-SEP-01
AKRON, OH 44333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-
ASTORIA-PACIFIC,INC. 510(k) NO: K010844(TRADITIONAL)
ATTN: RAYMOND L PAVITT PHONE NO : 503-657-3010
15130 S.E. 82ND DR. SE DECISION MADE: 21-SEP-01
P.O. BOX 830 510(k) SUMMARY AVAILABLE FROM FDA
CLAKAMAS, OR 97015-0830
DEVICE: AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K012154(TRADITIONAL)
ATTN: JAMES J ROGERS PHONE NO : 978-975-7530
39 HIGH STREET SE DECISION MADE: 19-SEP-01
NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC - CRISTAL
AUSTENAL, INC. 510(k) NO: K011674(TRADITIONAL)
ATTN: RONALD DUDEK PHONE NO : 773-735-0600
4101 WEST 51ST ST. SE DECISION MADE: 04-SEP-01
CHICAGO, IL 60632-4287 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVITA AGIL IT01 INSTANT DIGITAL THERMOMETER
AVITA INTERNATIONAL CORP. 510(k) NO: K012136(TRADITIONAL)
ATTN: ALLEN REICH PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142 SE DECISION MADE: 10-SEP-01
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON OUTLOOK WITH DOSECOM
B. BRAUN MEDICAL, INC. 510(k) NO: K011975(TRADITIONAL)
ATTN: LINDA MORGAN PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150 SE DECISION MADE: 19-SEP-01
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOMETER DEX TEST SENSOR
BAYER CORP. 510(k) NO: K012205(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928
1884 MILES AVE. SE DECISION MADE: 12-SEP-01
ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
BAYER DIAGNOSTICS CORP. 510(k) NO: K012904(SPECIAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 21-SEP-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/K
BD 510(k) NO: K012584(SPECIAL)
ATTN: PASQUALE AMATO PHONE NO : 201-847-4513
1 BECTON DR. MC 226 SE DECISION MADE: 06-SEP-01
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMU
BECKMAN COULTER, INC. 510(k) NO: K012208(TRADITIONAL)
ATTN: DENISE THOMPSON PHONE NO : 952-368-1202
1000 LAKE HAZELTINE DR. SE DECISION MADE: 07-SEP-01
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
BECTON DICKINSON & CO. 510(k) NO: K012351(TRADITIONAL)
ATTN: COLLEEN A ROHRBECK PHONE NO : 410-316-4988
7 LOVETON CIR. SE DECISION MADE: 18-SEP-01
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
BEST MANUFACTURING COMPANY 510(k) NO: K012899(TRADITIONAL)
ATTN: DAVID C YOUNG PHONE NO : 706-862-2302
579 EDISON STREET SE DECISION MADE: 18-SEP-01
MENLO, GA 30731 510(k) STATEMENT
DEVICE: SONOREAL 3D
BIO MEDI COM 510(k) NO: K012084(TRADITIONAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 26-SEP-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLENDERTONE FLEX, MODEL, 512
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K010335(TRADITIONAL)
ATTN: ROBERT DORMER PHONE NO : 202-737-5600
700 13TH ST. NW SE DECISION MADE: 27-SEP-01
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647
BIO-RAD LABORATORIES 510(k) NO: K012656(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 06-SEP-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEV
BIO-RAD LABORATORIES 510(k) NO: K012722(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 18-SEP-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK TDM CONTROL
BIO-RAD LABORATORIES 510(k) NO: K012741(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 12-SEP-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO NEUROMUSCULAR STIMULATOR, MODEL "NMS-DIGITAL"
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K010749(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 28-SEP-01
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: COPELAND MB RESURFACING HUMERAL HEADS
BIOMET MANUFACTURING, INC. 510(k) NO: K010657(TRADITIONAL)
ATTN: SARA A BAILEY PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-SEP-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: COPELAND MB/HA RESURFACING HUMERAL HEADS
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K010827(TRADITIONAL)
ATTN: SARA A BAILEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 14-SEP-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
BIONX IMPLANTS, INC. 510(k) NO: K012334(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 3 3165600
HERMIANKATU 6-8 L SE DECISION MADE: 19-SEP-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTE
BIOSAFE LABORATORIES, INC. 510(k) NO: K011970(TRADITIONAL)
ATTN: JACK A MAGGIORE PHONE NO : 773-693-0400
100 FIELD DRIVE #240 SE DECISION MADE: 26-SEP-01
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQUE SCALP VEIN SET
BIOTEQUE CORP. 510(k) NO: K012526(TRADITIONAL)
ATTN: ALLEN REICH PHONE NO : 928-773-9488
900 N. SWITZER CANYON DR. #142 SE DECISION MADE: 14-SEP-01
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST SPEP
BISCO, INC. 510(k) NO: K012032(TRADITIONAL)
ATTN: KATHY LONG PHONE NO : 847-534-6106
1100 WEST IRVING PARK RD. SE DECISION MADE: 17-SEP-01
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-WEAR
BISCO, INC. 510(k) NO: K012180(TRADITIONAL)
ATTN: STEVEN J DURAY PHONE NO : 847-534-6000
1100 WEST IRVING PARK RD. SE DECISION MADE: 05-SEP-01
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGER II ANGIOGRAPHIC CATHETER
BOSTON SCIENTIFIC/MEDI-TECH 510(k) NO: K011664(SPECIAL)
ATTN: JODI L GREENIZEN PHONE NO : 508-652-5008
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 07-SEP-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
BRAINLAB AG 510(k) NO: K012564(SPECIAL)
ATTN: STEFAN VILSMEIER PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 06-SEP-01
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION HIP
BRAINLAB, AG 510(k) NO: K010602(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9918680
AMMERTHALSTRASSE 8 SE DECISION MADE: 12-SEP-01
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION KNEE
BRAINLAB, AG 510(k) NO: K010612(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 06-SEP-01
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX
BRANAN MEDICAL CORP. 510(k) NO: K012541(SPECIAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 04-SEP-01
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: BRITESMILE BARRIER MATERIAL
BRITESMILE, INC. 510(k) NO: K010935(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 05-SEP-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY
C.R. BARD, INC. 510(k) NO: K012902(SPECIAL)
ATTN: STEPHANIE A ERSKINE PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 10-SEP-01
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
C.R. BARD, INC. 510(k) NO: K012913(SPECIAL)
ATTN: CAROL VIERLING PHONE NO : 770-385-2347
13183 HARLAND DR. SE DECISION MADE: 28-SEP-01
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG-2211 SELFCHECK ECG TRANSMITTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K012223(TRADITIONAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 10-SEP-01
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
CARDIOFOCUS, INC. 510(k) NO: K011988(TRADITIONAL)
ATTN: JOSEPH CURTIS PHONE NO : 508-285-1700
10 COMMERCE WAY SE DECISION MADE: 20-SEP-01
NORTON, MA 02766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYS
CARL ZEISS JENA GMBH 510(k) NO: K011877(TRADITIONAL)
ATTN: JOHNATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 26-SEP-01
WASHINGTONG, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CA
CATHEFFECTS, LLC. 510(k) NO: K011361(TRADITIONAL)
ATTN: SHAWN FOJTIK PHONE NO : 916-677-1790
1100 MELODY LANE; SUITE 108 SE DECISION MADE: 06-SEP-01
ROSEVILLE, CA 95678 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE INTUITIVE COLORIMETER
CERIUM OPTICAL TECHNOLOGIES, INC. 510(k) NO: K012298(TRADITIONAL)
ATTN: SOL AISENBERG PHONE NO : 508-651-0140
36 BRADFORD ROAD SE DECISION MADE: 26-SEP-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORMATE TLC BILITEST SYSTEM
CHROMATICS COLOR SCIENCES INTL., I510(k) NO: K001687(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 13-SEP-01
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE ACTIVATED CHECK VALVE
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K011888(TRADITIONAL)
ATTN: KEITH PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 10-SEP-01
DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHURCHILL MEDICAL SYSTEMS STOPCOCK
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K012157(TRADITIONAL)
ATTN: KEITH PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 11-SEP-01
DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
CIRCON VIDEO 510(k) NO: K011848(TRADITIONAL)
ATTN: JERRY CROUTHERS PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 11-SEP-01
SANTA BARBARA, CA 93117 510(k) STATEMENT
DEVICE: LOWSLEY SUPRAPUBIC TRACTOR
CIRCON VIDEO 510(k) NO: K012153(TRADITIONAL)
ATTN: WAYNE B STGRNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 19-SEP-01
SANTA BARBARA, CA 93117 510(k) STATEMENT
DEVICE: LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
CLINICAL CONTROLS, INC. 510(k) NO: K012907(TRADITIONAL)
ATTN: JAMES F GODFREY PHONE NO : 562-809-3389
12038 CENTRALIA ROAD, SUITE C SE DECISION MADE: 28-SEP-01
HAWAIIAN GARDENS, CA 90716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
COBE CARDIOVASCULAR, INC. 510(k) NO: K012898(SPECIAL)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 17-SEP-01
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN NERVE CUFF
COLLAGEN MATRIX, INC. 510(k) NO: K012814(TRADITIONAL)
ATTN: SHU-TUNG LI PHONE NO : 201-405-1477
509 COMMERCE STREET SE DECISION MADE: 21-SEP-01
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIVER TAMPONADE BALLOON
COOK, INC. 510(k) NO: K010450(TRADITIONAL)
ATTN: LISA HOPKINS PHONE NO : 800-346-2686
925 SOUTH CURRY PIKE SE DECISION MADE: 06-SEP-01
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .03
CORDIS CORP. 510(k) NO: K012590(SPECIAL)
ATTN: CHARLES (CHUCK) J RYAN PHONE NO : 908-412-7446
7 POWDER HORN DRIVE SE DECISION MADE: 07-SEP-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
CORGENIX, INC. 510(k) NO: K013018(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 20-SEP-01
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
CORGENIX, INC. 510(k) NO: K013077(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 28-SEP-01
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
CORGENIX, INC. 510(k) NO: K013079(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 28-SEP-01
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
CORGENIX, INC. 510(k) NO: K013080(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 28-SEP-01
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: ACCU-SPACE ABSORBABLE SEEDING SPACERS
CP MEDICAL 510(k) NO: K010621(TRADITIONAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 04-SEP-01
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE ACCLAIM DERMATOLOGY LASER
CYNOSURE, INC. 510(k) NO: K011828(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 07-SEP-01
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUS CS TROPONIN I CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K012233(TRADITIONAL)
ATTN: ELAINE H KINDELL PHONE NO : 302-631-6564
P.O. BOX 6101 SE DECISION MADE: 11-SEP-01
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MODIFICATION TO N/T PROTEIN CONTROL SL
DADE BEHRING, INC. 510(k) NO: K012468(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 04-SEP-01
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: MODIFICATION TO N PROTEIN STANDARD SL
DADE BEHRING, INC. 510(k) NO: K012470(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 28-SEP-01
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIE
DATEX-OHMEDA 510(k) NO: K012837(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 14-SEP-01
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
DEBIOTECH S.A. 510(k) NO: K011868(TRADITIONAL)
ATTN: SEAN CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 04-SEP-01
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128-2504
DEVICE: ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LP
DEPUY, INC. 510(k) NO: K011810(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 07-SEP-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012301(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 19-SEP-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K012795(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 28-SEP-01
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K012797(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 28-SEP-01
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCLA AND UNIVERSAL ABUTMENTS
DIAMODENT 510(k) NO: K010619(TRADITIONAL)
ATTN: JEFF RASSOLI PHONE NO : 714-632-3206
2737 EAST REGAL PARK AVENUE SE DECISION MADE: 28-SEP-01
ANAHEIM, CA 92806 510(k) STATEMENT
DEVICE: DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOF
DIDECO 510(k) NO: K010478(ABBREVIATED)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 W. 65TH WAY SE DECISION MADE: 27-SEP-01
ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
DIGENE CORP. 510(k) NO: K010891(TRADITIONAL)
ATTN: MARK A DEL VECCHIO PHONE NO : 301-944-7092
1201 CLOPPER RD SE DECISION MADE: 25-SEP-01
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
DIGENE CORP. 510(k) NO: K010892(TRADITIONAL)
ATTN: MARK A DEL VECCHIO PHONE NO : 301-944-7092
1201 CLOPPER RD SE DECISION MADE: 24-SEP-01
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
DIGENE CORP. 510(k) NO: K010893(TRADITIONAL)
ATTN: MARK A DEL VECCHIO PHONE NO : 301-944-7092
1201 CLOPPER RD SE DECISION MADE: 24-SEP-01
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEM
DR. ALBERT ZICKMANN 510(k) NO: K010882()
ATTN: ALBERT ZICKMANN PHONE NO : 773-769-2622
5455 N. SHERIDAN ROAD SE DECISION MADE: 28-SEP-01
#3608 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60640
DEVICE: VENTVIEW, MODEL 8414095
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K012177(SPECIAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 04-SEP-01
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DS30 HCY BLOOD COLLECTION TUBES
DREW SCIENTIFIC LTD. 510(k) NO: K012152(TRADITIONAL)
ATTN: ANDREW KENNEY PHONE NO : 441 229 432089
PARK RD., TELEMETER BLDG. SE DECISION MADE: 18-SEP-01
BARROW IN FURNESS, UNITED KINGDOM 510(k) STATEMENT
DEVICE: E-STETH ELECTRONIC STETHOSCOPE
E-MED INNOVATIONS, INC. 510(k) NO: K011898(TRADITIONAL)
ATTN: HUGH E HACKNEY PHONE NO : 214-740-8000
2200 ROSS AVENUE, SUITE 2200 SE DECISION MADE: 14-SEP-01
DALLAS, TX 75201-6776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEODESIC EEG SYSTEM, MODEL 200
ELECTRICAL GEODESICS, INC. 510(k) NO: K012079(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUNBINE DRIVE SE DECISION MADE: 19-SEP-01
PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K012926(SPECIAL)
ATTN: ERIC W KOEHLER PHONE NO : 651-523-6934
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 28-SEP-01
ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIOSCAN VERIFIT, MODEL VF-1
ETYMONIC DESIGN, INC. 510(k) NO: K012306(TRADITIONAL)
ATTN: WILLIAM A COLE PHONE NO : 519 268 3313
41 BYRON AVE. SE DECISION MADE: 21-SEP-01
DORCHESTER, ONTARIO, CANADA NOL 1G510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROTHERM, MODEL JK4
EUROLINK LLC. 510(k) NO: K011387(TRADITIONAL)
ATTN: WILLIAM RITTMAN PHONE NO : 781-334-6654
77 LOCKSLEY RD. SE DECISION MADE: 06-SEP-01
LYNNFIELD, MA 01940 510(k) STATEMENT
DEVICE: EXEL INJECTION PLUG WITH CAP
EXELINT INTL. CO. 510(k) NO: K011405(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 27-SEP-01
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: INSIGHT MILLENNIUM PLUS
FASSTECH 510(k) NO: K011964(TRADITIONAL)
ATTN: LEE BRODY PHONE NO : 781-229-1500
155 MIDDLESEX TURNPIKE SE DECISION MADE: 20-SEP-01
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
FISHER DIAGNOSTICS 510(k) NO: K010750(TRADITIONAL)
ATTN: NADIA GREENIDGE PHONE NO : 540-869-3200
8365 VALLEY PIKE SE DECISION MADE: 07-SEP-01
MIDDLETOWN, VA 22645-0307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF2
FIXANO SA 510(k) NO: K012062(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O BOX 12038 SE DECISION MADE: 27-SEP-01
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOFIX
FIXANO SA 510(k) NO: K012078(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O BOX 12038 SE DECISION MADE: 27-SEP-01
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
GE MEDICAL SYSTEMS 510(k) NO: K012775(SPECIAL)
ATTN: GEOFFREY COCHRANE PHONE NO : 330-487-6638
8380 DARROW ROAD SE DECISION MADE: 18-SEP-01
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K012836(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 07-SEP-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE SIGNA ASSET IMAGING OPTION
GE MEDICAL SYSTEMS 510(k) NO: K012970(SPECIAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 24-SEP-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VISION NUCLEAR MEDICINE WORKSTATION
GENERAL ELECTRIC CO. 510(k) NO: K012568(SPECIAL)
ATTN: KEVIN M MURROCK PHONE NO : 330-487-6635
8380 DARROW ROAD SE DECISION MADE: 06-SEP-01
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC,
GETINGE/CASTLE, INC. 510(k) NO: K012573(SPECIAL)
ATTN: FREDERICK R CATT PHONE NO : 716-272-5013
1777 EAST HENRIETTA RD. SE DECISION MADE: 05-SEP-01
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP-ONE
GI SUPPLY 510(k) NO: K012411(TRADITIONAL)
ATTN: FRANK CARTER PHONE NO : 717-761-1171
200 GRANDVIEW AVE. SE DECISION MADE: 25-SEP-01
CAMP HILL, PA 17011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE EDTA K2 GEL TUBES
GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K012043(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 24-SEP-01
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
GUIDANT CORP. 510(k) NO: K012050(SPECIAL)
ATTN: SABA MODJARRAD PHONE NO : 408-845-1067
3200 LAKESIDE DR. SE DECISION MADE: 06-SEP-01
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: HARRISON HAND HELD ADJUSTING INSTRUMENT
HARRISON CBP SEMINARS 510(k) NO: K010851(TRADITIONAL)
ATTN: SANG HARRISON PHONE NO : 307-789-2088
P.O. BOX 1590 SE DECISION MADE: 18-SEP-01
EVANSTON, WY 82931-1590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLATELETWORKS
HELENA LABORATORIES 510(k) NO: K012723(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 28-SEP-01
P.O. BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: RAICHEM MULTI-ANALYTE CALIBRATOR
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K012250(ABBREVIATED)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 24-SEP-01
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: ALLERSHARP ALLERGY SKIN TESTER
HMB MEDICAL CONCEPTS, LTD. 510(k) NO: K011979(TRADITIONAL)
ATTN: GAVIN MCLACHLAN PHONE NO : 678-624-9718
1695 RIDGE HAVEN RUN SE DECISION MADE: 14-SEP-01
ALPHARETTA, GA 30022 510(k) STATEMENT
DEVICE: XIA STAINLESS STEEL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K012870(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 24-SEP-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STS RANGE , MODELS STS20,STS30,STS40
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K012008(TRADITIONAL)
ATTN: AUDREY WITKO PHONE NO : 732-578-9898
40 CHRISTOPHER WAY SE DECISION MADE: 21-SEP-01
EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREE
HYPOGUARD USA, INC. 510(k) NO: K010973(TRADITIONAL)
ATTN: BRUCE MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 11-SEP-01
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3I CALCIUM SULFATE BONE CEMENT
IMPLANT INNOVATIONS, INC. 510(k) NO: K012047(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 219-267-6639
56 E BELL DRIVE SE DECISION MADE: 19-SEP-01
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3I LOCATER ABUTMENT SYSTEM
IMPLANT INNOVATIONS, INC. 510(k) NO: K012911(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 28-SEP-01
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
IMPLEX CORP. 510(k) NO: K012866(SPECIAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 26-SEP-01
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL RECOMBI PLASTIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K012768(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 18-SEP-01
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR-MONOGEN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K012901(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 27-SEP-01
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196,
INTERPORE CROSS INTL. 510(k) NO: K012871(SPECIAL)
ATTN: LYNN M RODARTI PHONE NO : 949-543-3200
181 TECHNOLOGY DR. SE DECISION MADE: 13-SEP-01
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M71 POWER WHEELCHAIR
INVACARE CORP. 510(k) NO: K012927(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 19-SEP-01
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: JAS CARBON DIOXIDE LIQUID REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K012332(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 06-SEP-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
JMS CO., LTD. 510(k) NO: K002352(TRADITIONAL)
ATTN: KEISUKE URATOMI PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 06-SEP-01
HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT
DEVICE: JMS APHERESIS NEEDLE SET ACCORDION TYPE
JMS CO., LTD. 510(k) NO: K002394(TRADITIONAL)
ATTN: KEISUKE URATOMI PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 05-SEP-01
HIROSHIMA 730-8652, JAPAN 730-8652510(k) STATEMENT
DEVICE: MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
JOHNSON & JOHNSON MEDICAL (CHINA) 510(k) NO: K012124(TRADITIONAL)
ATTN: BEN TANG PHONE NO : 862 146 435010
#75 NAN GU ZHI ROAD SE DECISION MADE: 19-SEP-01
MONHANG, SHANGHAI, CHINA 200245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
KARL STORZ ENDOSCOPY 510(k) NO: K011841(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 10-SEP-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
KENSEY NASH CORP. 510(k) NO: K011943(TRADITIONAL)
ATTN: JULIE N BRODERICK PHONE NO : 610-594-7113
55 EAST UWCHLAN AVE. SE DECISION MADE: 19-SEP-01
MARSH CREEK CORP. CENTER 510(k) SUMMARY AVAILABLE FROM FDA
EXTON, PA 19341-1247
DEVICE: OPTIBOND SOLO PLUS 3
KERR DENTAL MATERIALS CENTER 510(k) NO: K011908(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 06-SEP-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CLEARFIL PHOTO BOND
KURARAY MEDICAL INC. 510(k) NO: K012432(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 04-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: MODIFICATION TO ALLOY PRIMER
KURARAY MEDICAL INC. 510(k) NO: K012436(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 04-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: MODIFICATION TO PANAVIA 21
KURARAY MEDICAL INC. 510(k) NO: K012438(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 05-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: MODIFICATION TO CLEARFIL LINER BOND 2V
KURARAY MEDICAL INC. 510(k) NO: K012440(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 05-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: PANAVIA F
KURARAY MEDICAL INC. 510(k) NO: K012441(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 06-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: MODIFICATION TO CLEARFIL SE BOND
KURARAY MEDICAL INC. 510(k) NO: K012442(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 10-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL CORE NEW BOND
KURARAY MEDICAL INC. 510(k) NO: K012703(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 10-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL ST OPAQUER
KURARAY MEDICAL INC. 510(k) NO: K012704(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 10-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL PHOTO CORE
KURARAY MEDICAL INC. 510(k) NO: K012705(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 11-SEP-01
200 PARK AVENUE 510(k) STATEMENT
NEW YORK, NY 10166
DEVICE: ESTENIA
KURARAY MEDICAL INC. 510(k) NO: K012707(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 13-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL REPAIR
KURARAY MEDICAL INC. 510(k) NO: K012729(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 13-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL PORCELAIN BOND ACTIVATOR
KURARAY MEDICAL INC. 510(k) NO: K012730(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 13-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CARIES DETECTOR
KURARAY MEDICAL INC. 510(k) NO: K012733(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 14-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL NEW BOND
KURARAY MEDICAL INC. 510(k) NO: K012734(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 14-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL DC CEMENT
KURARAY MEDICAL INC. 510(k) NO: K012735(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 800-879-1676
30TH FL. METLIFE BUILDING SE DECISION MADE: 14-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CHROMA ZONE COLOR STAIN
KURARAY MEDICAL INC. 510(k) NO: K012737(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 14-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: CLEARFIL AP-X
KURARAY MEDICAL INC. 510(k) NO: K012740(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 14-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: TEETHMATE F-1
KURARAY MEDICAL INC. 510(k) NO: K012742(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
30TH FL. METLIFE BUILDING SE DECISION MADE: 14-SEP-01
200 PARK AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10166
DEVICE: LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
LEAD-LOK, INC. 510(k) NO: K010431(TRADITIONAL)
ATTN: CHRIS HEALY PHONE NO : 208-263-5071
500 AIRPORT WAY SE DECISION MADE: 06-SEP-01
SANDPOINT, ID 83864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
LH MEDICAL PRODUCTS, INC. 510(k) NO: K011340(TRADITIONAL)
ATTN: LONNIE HUTSON PHONE NO : 877-592-0523
301 EAST ARROW HWY., SUITE 104 SE DECISION MADE: 21-SEP-01
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
LH MEDICAL PRODUCTS, INC. 510(k) NO: K011341(TRADITIONAL)
ATTN: LONNIE HUTSON PHONE NO : 877-592-0523
301 EAST ARROW HWY., SUITE 104 SE DECISION MADE: 21-SEP-01
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LH 500 ENTERAL FEEDING GRAVITY BAG SET
LH MEDICAL PRODUCTS, INC. 510(k) NO: K011343(TRADITIONAL)
ATTN: LONNIE HUTSON PHONE NO : 877-592-0523
301 EAST ARROW HWY., SUITE 104 SE DECISION MADE: 21-SEP-01
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS IMPLANT SYSTEM DECIVE
M.I.S. IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K003191(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 729-767-0002
BEIT HAPA'AMON, SUITE 206 SE DECISION MADE: 28-SEP-01
BOX 124;20 HATA'AS ST. 510(k) STATEMENT
KFAR SABA, ISRAEL 44425
DEVICE: MACROPORE FX, PS, NS, LP
MACROPORE, INC. 510(k) NO: K012413(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 18-SEP-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEL PRINT CYAN ALGINATES
MANUFACTURERA DENTAL CONTINENTAL 510(k) NO: K011785(TRADITIONAL)
ATTN: GARY S MOCNIK PHONE NO : 949-363-2953
27881 LA PAZ ROAD, #G 316 SE DECISION MADE: 04-SEP-01
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: MX8000 IDT CT SYSTEM
MARCONI MEDICAL SYSTEMS, INC. 510(k) NO: K012009(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER ROAD SE DECISION MADE: 13-SEP-01
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND
MATANG MFG. SDN. BHD. 510(k) NO: K012558(TRADITIONAL)
ATTN: KOK-KEE HON PHONE NO : 703-941-7656
6324 MEETING HOUSE WAY SE DECISION MADE: 17-SEP-01
ALEXANDRIA, VA 22312-1718 510(k) STATEMENT
DEVICE: MICROCRUISER PLUS INTRODUCER SET
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K011790(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
3600 S.W. 47TH AVE. SE DECISION MADE: 05-SEP-01
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQA, SPERM QUALITY ANALYZER
MEDICAL ELECTRONIC SYSTEMS, LLC 510(k) NO: K012352(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768
6363 GREENWICH DRIVE SE DECISION MADE: 21-SEP-01
SUITE 220 510(k) STATEMENT
SAN DIEGO, CA 92122
DEVICE: PORTABLE INTENSIVE CARE UNIT
MEDICAL RESEARCH LABORATORIES, INC510(k) NO: K012030(TRADITIONAL)
ATTN: JOEL ORLINSKY PHONE NO : 847-520-0300
1000 ASBURY DR. NO.17 SE DECISION MADE: 24-SEP-01
BUFFALO GROVE, IL 60089 510(k) STATEMENT
DEVICE: SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON AMERICA, INC. 510(k) NO: K012867(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 12-SEP-01
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON AMERICA, INC. 510(k) NO: K012887(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 12-SEP-01
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
MEDLINE INDUSTRIES, INC. 510(k) NO: K011240(TRADITIONAL)
ATTN: STACEY L BOLEN PHONE NO : 847-837-2843
ONE MEDLINE PLACE SE DECISION MADE: 13-SEP-01
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: GSA GENITO SENSORY ANALYZER
MEDOC LTD. ADVANCED MEDICAL SYSTEM510(k) NO: K010981(TRADITIONAL)
ATTN: ANN QUINLAN-SMITH PHONE NO : 952-593-1553
11660 WAYZATA BLVD. SE DECISION MADE: 20-SEP-01
MINNETONKA, MN 55305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K012743(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 763-391-9183
7611 NORTHLAND DR. SE DECISION MADE: 14-SEP-01
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K012747(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 763-391-9183
7611 NORTHLAND DR. SE DECISION MADE: 14-SEP-01
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFA
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K013084(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 763-391-9183
7611 NORTHLAND DR. SE DECISION MADE: 27-SEP-01
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K012428(SPECIAL)
ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332
11811 WILLOWS RD NE SE DECISION MADE: 28-SEP-01
P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073-9706
DEVICE: VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K003780(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 28-SEP-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MP3CF ELECTRIC WHEELCHAIR
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K012802(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 941-772-0579
P.O. BOX 150356 SE DECISION MADE: 18-SEP-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: MHS 5000
MICRO HEALTH SYSTEMS INC. 510(k) NO: K011981(TRADITIONAL)
ATTN: ROBERT BARNES PHONE NO : 954-575-1076
7407 DOVER LANE SE DECISION MADE: 05-SEP-01
PARKLAND, FL 33067 510(k) STATEMENT
DEVICE: BLY-501 ADAPTOR
MICROMEDICAL INDUSTRIES, LTD. 510(k) NO: K012540(SPECIAL)
ATTN: STEPHEN CRESSWELL PHONE NO : 011 61 755739742
11 TECHNOLOGY DR. SE DECISION MADE: 26-SEP-01
LABRADOR, QUEENSLAND, AUSTRALIA 42510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
MOLDED PRODUCTS 510(k) NO: K010712(ABBREVIATED)
ATTN: ELISE JOHNSTON PHONE NO : 712-755-5557
601 DURANT ST. SE DECISION MADE: 27-SEP-01
HARLAN, IA 51537 510(k) STATEMENT
DEVICE: AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
MONAGHAN MEDICAL CORP. 510(k) NO: K012939(SPECIAL)
ATTN: JAMES A COCHIE PHONE NO : 518-561-7330
5 LATOUR AVE., SUITE 1600 SE DECISION MADE: 28-SEP-01
P.O. BOX 2805 510(k) STATEMENT
PLATTSBURGH, NY 12901
DEVICE: MINI MULTILEAF COLLIMATOR, MODEL KMI
MRC SYSTEMS GMBH 510(k) NO: K011816(TRADITIONAL)
ATTN: JORG STEIN PHONE NO : 496 221 1380300
HANS-BUNTE-STR. 10 SE DECISION MADE: 07-SEP-01
HEIDELBERG, GERMANY 69123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: QWH-420 WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K013099(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 25-SEP-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: ELEC-MATE E
NAKANISHI, INC. 510(k) NO: K011926(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 11-SEP-01
TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT
DEVICE: SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005
NATIONAL CUSTOM ENT., INC. 510(k) NO: K012229(TRADITIONAL)
ATTN: DON PELLETIER PHONE NO : 952-890-1360
1133 EAST CLIFF RD. SE DECISION MADE: 10-SEP-01
BURNSVILLE, MN 55337 510(k) STATEMENT
DEVICE: MEDFUSION 2001 & 2010, MODEL N7215IWC
NATIONAL CUSTOM ENT., INC. 510(k) NO: K012259(TRADITIONAL)
ATTN: DON PELLETIER PHONE NO : 952-890-1360
1133 EAST CLIFF RD. SE DECISION MADE: 12-SEP-01
BURNSVILLE, MN 55337 510(k) STATEMENT
DEVICE: BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
NATIONAL CUSTOM ENT., INC. 510(k) NO: K012262(TRADITIONAL)
ATTN: DON PELLETIER PHONE NO : 952-890-1360
1133 EAST CLIFF RD. SE DECISION MADE: 12-SEP-01
BURNSVILLE, MN 55337 510(k) STATEMENT
DEVICE: SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IW
NATIONAL CUSTOM ENT., INC. 510(k) NO: K012266(TRADITIONAL)
ATTN: DON PELLETIER PHONE NO : 952-890-1360
1133 EAST CLIFF RD. SE DECISION MADE: 12-SEP-01
BURNSVILLE, MN 55337 510(k) STATEMENT
DEVICE: DENTORIUM CONVERTIBLE ACRYLIC
NATS CORP. 510(k) NO: K011820(TRADITIONAL)
ATTN: RICHARD C LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 05-SEP-01
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), M
NEU COLL 510(k) NO: K000122(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 650-320-5789
25OO FABER PLACE SE DECISION MADE: 20-SEP-01
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSOFT'S SOURCE
NEUROSOFT, INC. 510(k) NO: K011241(TRADITIONAL)
ATTN: ELVIRA GARCIA PHONE NO : 915-845-5600
5700 CROMO, SUITE 100 SE DECISION MADE: 19-SEP-01
EL PASO, TX 79912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE I.C.O.S SCREW
NEWDEAL S.A. 510(k) NO: K011821(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 06-SEP-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE TAC' PIN
NEWDEAL S.A. 510(k) NO: K011875(TRADITIONAL)
ATTN: MORGANE GRENIER PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 06-SEP-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXAN SYSTEM, MODEL NX-301
NEXAN LTD 510(k) NO: K010424(TRADITIONAL)
ATTN: DAVID L WEST PHONE NO : 301-272-3113
1801 ROCKVILLE PIKE SE DECISION MADE: 04-SEP-01
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIE
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K011128(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-240-5260
33051 CALLE AVIADOR SE DECISION MADE: 06-SEP-01
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE EMG ELECTRODES
NICOLET BIOMEDICAL, INC. 510(k) NO: K011818(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 06-SEP-01
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOREHAB SYSTEM
NICOLET BIOMEDICAL, INC. 510(k) NO: K011823(ABBREVIATED)
ATTN: GARY J SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 06-SEP-01
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES,
NIHON KOHDEN AMERICA, INC. 510(k) NO: K011918(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 12-SEP-01
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NSI HEXED AND NON-HEXED IMPLANT SYSTEM
NSI 510(k) NO: K003620(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10565 LEE HIGHWAY SE DECISION MADE: 19-SEP-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
FAIRFAX,, VA 22030
DEVICE: OLDELFT THORASCAN MODEL NUMBER 180T
NUCLETRON CORP. 510(k) NO: K012165(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 19-SEP-01
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNICARE DENTAL IMPLANT SYSTEM
OMNICARE DENTAL IMPLANT CENTER 510(k) NO: K000035(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 28-SEP-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM ANCHOR & INSERTER
OPUS MEDICAL, INC. 510(k) NO: K012125(TRADITIONAL)
ATTN: MARK RITCHART PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 17-SEP-01
SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT
DEVICE: SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE
ORTHOGEN CORP. 510(k) NO: K011403(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 11-SEP-01
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRING
ORTHOVITA, , INC. 510(k) NO: K011087(TRADITIONAL)
ATTN: ANGIE IDE PHONE NO : 610-407-5231
45 GREAT VALLEY PKWY. SE DECISION MADE: 19-SEP-01
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R120 MODULAR TOTAL HIP SYSTEM
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K011774(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 05-SEP-01
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: OTO-CEM
OTOTECH, INC. 510(k) NO: K011338(TRADITIONAL)
ATTN: MICHAEL G FARROW PHONE NO : 202-223-0157
1625 K STREET, NW SE DECISION MADE: 13-SEP-01
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: PRE-POWDERED NITRILE EXAMINATION GLOVES
P.T. HEALTHCARE GLOVINDO 510(k) NO: K010232(TRADITIONAL)
ATTN: ELLEN HUTAPEA PHONE NO : 620 616 50015
JL. KOL. YOS SUDARSO K.M. 10 SE DECISION MADE: 21-SEP-01
KAWASAN INDUSRI MEDAN (KIM) 510(k) STATEMENT
MEDAN 10340, INDONESIA 10340
DEVICE: ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 A
PACE MEDICAL 510(k) NO: K011980()
ATTN: ROBERT C MACE PHONE NO : 781-890-5656
391 TOTTEN POND RD. SE DECISION MADE: 12-SEP-01
WALTHAM, MA 02451 510(k) STATEMENT
DEVICE: DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
PACE MEDICAL 510(k) NO: K012392(TRADITIONAL)
ATTN: ROBERT C MACE PHONE NO : 781-890-5656
391 TOTTEN POND RD. SE DECISION MADE: 04-SEP-01
WALTHAM, MA 02451 510(k) STATEMENT
DEVICE: "PADPRO SYSTEM" DEFIBRILLATOR ELECTRODE ADAPTERS
PADPRO LLC. 510(k) NO: K003548(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O.BOX 7007 SE DECISION MADE: 04-SEP-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR DERMALUX PULSED LIGHT SYSTEM
PALOMAR 510(k) NO: K010618(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 10-SEP-01
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC TEMPORARY FILLING
PARKELL, INC. 510(k) NO: K012360(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 06-SEP-01
P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA
FARMINGDALE, NY 11735
DEVICE: PATTON ENDO-BAG
PATTON MEDICAL CORP. 510(k) NO: K012150(TRADITIONAL)
ATTN: MICHAEL T PATTON PHONE NO : 512-916-4880
1000 WESTBANK DRIVE SE DECISION MADE: 20-SEP-01
SUITE 5A200 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: UNIVERSAL DENTAL COPING (UDC)
PAXMED INTERNATIONAL 510(k) NO: K010467()
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 28-SEP-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
PAXMED INTERNATIONAL 510(k) NO: K011223(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 20-SEP-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPF ACETABULAR CUP
PLUS ORTHOPEDICS 510(k) NO: K011836(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 888-741-7587
6055 LUSK BLVD. SE DECISION MADE: 07-SEP-01
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGID GAS PERMEABLE CONTACT LENS SOLUTION
POLYMER TECHNOLOGY CORP. 510(k) NO: K011945(TRADITIONAL)
ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638
1400 N. GOODMAN STREET SE DECISION MADE: 12-SEP-01
ROCHESTER, NY 14692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIFURCATED VACCINATING NEEDLE
PRECISION MEDICAL PRODUCTS, INC. 510(k) NO: K012515(TRADITIONAL)
ATTN: RONALD D WOLFE PHONE NO : 717-335-3700
12 INDUSTRIAL WAY SE DECISION MADE: 19-SEP-01
DENVER, PA 17517 510(k) STATEMENT
DEVICE: COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K012160(TRADITIONAL)
ATTN: BARRY HALE PHONE NO : 816-322-4641
7707 E. 201 TERR SE DECISION MADE: 27-SEP-01
BELTON, MO 64012 510(k) STATEMENT
DEVICE: AQUANET, MODEL EC 2000
PRIME PACIFIC INTL. QUALITY PRODUC510(k) NO: K000031(TRADITIONAL)
ATTN: OTHMAR VOGEL PHONE NO : 604 929 7019
145 RIVERSIDE DR. SE DECISION MADE: 10-SEP-01
NORTH VANCOUVER, CANADA V7H 1T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SU
PROCTER & GAMBLE CO. 510(k) NO: K011996(TRADITIONAL)
ATTN: MARK M ANDERSON PHONE NO : 513-634-5196
6110 CENTER HILL AVENUE SE DECISION MADE: 19-SEP-01
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE LATEX CONDOM
QINGDAO SHUANG DIE LATEX PRODUCTIO510(k) NO: K012653(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK ROAD SE DECISION MADE: 21-SEP-01
DURHAM, NC 27713 510(k) STATEMENT
DEVICE: QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
QUANTUM BIOENGINEERING, LTD. 510(k) NO: K002241()
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
201 UNUVERSITY DR., SUITE 101 SE DECISION MADE: 20-SEP-01
PLANTATION, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM VERSATILITY IMPLANT SYSTEM
QUANTUM BIOENGINEERING, LTD. 510(k) NO: K991250(TRADITIONAL)
ATTN: RAUL R MENA PHONE NO : 954-474-4707
201 UNUVERSITY DR., SUITE 101 SE DECISION MADE: 20-SEP-01
PLANTATION, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFARED EAR THERMOMETER, MODEL TH8 SERIES
RADIANT INNOVATION, INC. 510(k) NO: K011059(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 17-SEP-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: RANDOX LIPOPROTEIN
RANDOX LABORATORIES, LTD. 510(k) NO: K011568(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 28-SEP-01
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX THERAPEUTIC DRUG CALIBRATOR
RANDOX LABORATORIES, LTD. 510(k) NO: K012318(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 44 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 12-SEP-01
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: RANDOX GENTAMICIN
RANDOX LABORATORIES, LTD. 510(k) NO: K012978(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 18-SEP-01
CRUMLIN, IRELAND BT29 4QY 510(k) STATEMENT
DEVICE: PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVIC
REHABILICARE, INC. 510(k) NO: K011017(TRADITIONAL)
ATTN: EDWARD F VALDEZ PHONE NO : 612-638-0448
1811 OLD HIGHWAY 8 SE DECISION MADE: 24-SEP-01
NEW BRIGHTON, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINETIC CANNULA
RELIANCE MEDICAL CORP. 510(k) NO: K012042(TRADITIONAL)
ATTN: ROBERT W NICKS PHONE NO : 970-986-5345
730 INDEPENDENT AVE. SE DECISION MADE: 20-SEP-01
GRAND JUNCTION, CO 81505 510(k) STATEMENT
DEVICE: RHS HELMET
RESTORATIVE HEALTH SVS, INC. 510(k) NO: K012007(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301 K STREET, N.W. SE DECISION MADE: 19-SEP-01
SUITE 1100-EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005-3373
DEVICE: SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCE
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K011911(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 17-SEP-01
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT TRANSFERRIN VER.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012371(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 19-SEP-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT TRANSFERRIN VER.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012393(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 19-SEP-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URISYS 2400 URINE TEST STRIP
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012397(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 26-SEP-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIDOS
SCANDITRONIX MEDICAL AB 510(k) NO: K011763(TRADITIONAL)
ATTN: ALF OHMAN PHONE NO : 461 818 0700
STALGATAN 14 SE DECISION MADE: 05-SEP-01
UPPSALA S-754 50, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIFUNCTION ENDOSCOPIC INSTRUMENT
SEEDLING ENTERPRISES. LLC. 510(k) NO: K012033(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRIAL SE DECISION MADE: 20-SEP-01
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTA
SEMPERMED USA, INC. 510(k) NO: K011407(TRADITIONAL)
ATTN: KATIE LEVINSON PHONE NO : 727-787-7250
30798 US HWY. 19 NORTH SE DECISION MADE: 11-SEP-01
PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
SENORX, INC. 510(k) NO: K012004(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 25-SEP-01
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF
SENORX, INC. 510(k) NO: K012023(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 12-SEP-01
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
SENORX, INC. 510(k) NO: K012799(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 04-SEP-01
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUE
SGMP CO., LTD. 510(k) NO: K012857(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 21-SEP-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEI
SGMP CO., LTD. 510(k) NO: K012860(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 21-SEP-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AN
SGMP CO., LTD. 510(k) NO: K012863(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 21-SEP-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 M
SHEN WEI (USA), INC. 510(k) NO: K011044(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 10-SEP-01
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROG
SHEN WEI (USA), INC. 510(k) NO: K011045(TRADITIONAL)
ATTN: BELLE CHOU PHONE NO : 520-845-0023
2845 WHIPPLE RD. SE DECISION MADE: 11-SEP-01
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS
SHEN WEI (USA), INC. 510(k) NO: K011961(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 26-SEP-01
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDER-FREE GREEN "BARRIER-PRO" SYNTHETIC BUTADIENE COPOLYMER EX
SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K011613(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 17-SEP-01
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG BRILLIANCE PLASTIC CO510(k) NO: K012711(TRADITIONAL)
ATTN: HUAN CHUNG LI PHONE NO : 978-436-9980
17A STERLING ROAD SE DECISION MADE: 18-SEP-01
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: NUMARIS 4VA15A
SIEMENS MEDICAL CORP. 510(k) NO: K012202(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVE. SOUTH SE DECISION MADE: 27-SEP-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LA
SMART GLOVE CORP. SDN BHD 510(k) NO: K011066(TRADITIONAL)
ATTN: NG-YEW SOON PHONE NO : 603 391 6100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 11-SEP-01
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: STERILE NITRILE SURGICAL GLOVES (POWDERED)
SMART GLOVE CORP. SDN BHD 510(k) NO: K012479(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 26-SEP-01
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
SMITH & NEPHEW, INC. 510(k) NO: K011944(TRADITIONAL)
ATTN: STEVEN JACKSON PHONE NO : 405-936-3085
3600 NW 138TH STREET SE DECISION MADE: 19-SEP-01
OKLAHOMA CITY, OK 73134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
SODEM SYSTEMS 510(k) NO: K012456(TRADITIONAL)
ATTN: CAROLE BURNIER PHONE NO : 41 22 7949696
110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 21-SEP-01
GENEVA, SWITZERLAND CH-1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX EV HEMOSTASIS INTRODUCER
ST.JUDE MEDICAL 510(k) NO: K012922(SPECIAL)
ATTN: KIRK S HONOUR PHONE NO : 952-352-9737
14901 DEVEAU PL. SE DECISION MADE: 25-SEP-01
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY SOFT QD MICRO INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K012845(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 14-SEP-01
LOS ALTOS HILLS, CA 94022-4583 510(k) STATEMENT
DEVICE: STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K012270(TRADITIONAL)
ATTN: ALISA MILLER PHONE NO : 408-567-9100
2590 WALSH AVE. SE DECISION MADE: 28-SEP-01
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.25MM SPLINE TWIST IMPLANT
SULZER DENTAL, INC. 510(k) NO: K012055(TRADITIONAL)
ATTN: FOSTER BOOP PHONE NO : 760-431-9515
1900 ASTON AVE. SE DECISION MADE: 06-SEP-01
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECH
SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K011806(TRADITIONAL)
ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018
651 CAMPUS DR. SE DECISION MADE: 07-SEP-01
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
SULZER ORTHOPEDICS, INC. 510(k) NO: K011954(TRADITIONAL)
ATTN: BRUCE WALDON PHONE NO : 512-432-9482
9900 SPECTRUM DR. SE DECISION MADE: 19-SEP-01
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
SULZER SPINE-TECH 510(k) NO: K012173(SPECIAL)
ATTN: KRISTYN M BENSON PHONE NO : 952-830-6273
7375 BUSH LAKE RD. SE DECISION MADE: 28-SEP-01
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERSTITCH VASCULAR SUTURING DEVICE
SUTURA, INC. 510(k) NO: K012865(SPECIAL)
ATTN: JAMES BONDS PHONE NO : 714-437-9801
17080 NEWHOPE ST. SE DECISION MADE: 25-SEP-01
FOUNTAIN VALLEY, CA 92708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND SOLO PLUS ACTIVATOR
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K012082(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 20-SEP-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRUDE MODIFIED
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K012405(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 04-SEP-01
ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LCP PROXIMAL HUMERUS PLATES
SYNTHES (USA) 510(k) NO: K011815(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-SEP-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
SYNTHES (USA) 510(k) NO: K011857(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 12-SEP-01
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
SYNTHES (USA) 510(k) NO: K012114(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 28-SEP-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYSMEX UF-50
SYSMEX CORP. 510(k) NO: K012372(TRADITIONAL)
ATTN: CHRIS STUKEL PHONE NO : 847-726-3523
GILMER ROAD SE DECISION MADE: 28-SEP-01
6699 RFD 510(k) SUMMARY AVAILABLE FROM FDA
LONG GROVE, IL 60047-9596
DEVICE: TE ME NA POLYSTIM NERVE STIMILATOR
TE ME NA S.A.R.L. 510(k) NO: K990323(TRADITIONAL)
ATTN: JOE HARMS PHONE NO : 813-818-8705
390 SCARLET BLVD SE DECISION MADE: 28-SEP-01
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
TELEMEDIC SYSTEMS, INC. 510(k) NO: K010732(TRADITIONAL)
ATTN: STENEN CHERNOFF PHONE NO : 425-861-8262
P.O. BOX 3515 SE DECISION MADE: 27-SEP-01
REDMOND, WA 98073-3515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUARIUSNET SERVER
TERARECON, INC. 510(k) NO: K012086(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 13-SEP-01
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389
DEVICE: XBO1-824-18/19/20 BIOPSY FORCEPS
THE OLYMPUS OPTICAL CO. 510(k) NO: K012074(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 25-SEP-01
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOKUYAMA M-BOND
TOKUYAMA AMERICA, INC. 510(k) NO: K011854(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040
2000 M STREET, NW SE DECISION MADE: 04-SEP-01
SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: G7 AUTOMATED HPLC ANALYZER
TOSOH MEDICS, INC. 510(k) NO: K011434(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 800-248-6764
347 OYSTER POINT BLVD., SE DECISION MADE: 18-SEP-01
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SOUTH SAN FRANCISCO, CA 94080
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K012565(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 12-SEP-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: CLINCARE LATEX SURGEON'S GLOVE
TTK HEALTHCARE LTD. 510(k) NO: K012067(TRADITIONAL)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK ROAD SE DECISION MADE: 17-SEP-01
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERASTEP
UNITED STATES SURGICAL, A DIVISION510(k) NO: K012539(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 06-SEP-01
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIPLANT DENTAL IMPLANT SYSTEM
UNIVERSAL IMPLANT SYSTEMS, INC. 510(k) NO: K011574(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 28-SEP-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K011800(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 27-SEP-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V*CARE MANUAL RESUSCITATOR
VENTLAB CORP. 510(k) NO: K012842(SPECIAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 800-593-4654
2934 HWY. 601 NORTH SE DECISION MADE: 18-SEP-01
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: VYGON SPLIT CANNULA INTRODUCER
VYGON CORP. 510(k) NO: K010913(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 201-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 28-SEP-01
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: PRECLUDE PERICARDIAL MEMBRANE
W.L. GORE & ASSOCIATES,INC 510(k) NO: K012098(TRADITIONAL)
ATTN: R. LARRY PRATT PHONE NO : 520-779-2771
3750 WEST KILTIE LN. SE DECISION MADE: 20-SEP-01
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. UREA UV CINETICA AA
WIENER LABORATORIES S.A.I.C. 510(k) NO: K012260(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191
2944 RIOBAMBA SE DECISION MADE: 19-SEP-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML C
WIENER LABORATORIES S.A.I.C. 510(k) NO: K012329(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 21-SEP-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ALUMINA CERAMIC FEMORAL HEADS, MODEL 6418 SERIE
ZIMMER, INC. 510(k) NO: K012793(SPECIAL)
ATTN: KAREN CAIN PHONE NO : 219-372-4219
P.O. BOX 708 SE DECISION MADE: 06-SEP-01
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 282
TOTAL WITH SUMMARIES 217
TOTAL WITH STATEMENTS 65
Updated 5/28/2002
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