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510(k)s Final Decisions Rendered for October 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-OCT-2001 THROUGH 31-OCT-2001
DEVICE: EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODE
138 MEDICAL SUPPLIES, INC. 510(k) NO: K000741(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 24-OCT-01
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: W & H ASSISTINA
A-DEC, INC. 510(k) NO: K010127(TRADITIONAL)
ATTN: LOVENA STANDRIDGE PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 05-OCT-01
NEWBERG, OR 97132-9257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
ACCUMETRICS, INC. 510(k) NO: K011337(TRADITIONAL)
ATTN: RHONDA MOE PHONE NO : 858-404-8238
3985 SORRENTO VALLEY BLVD SE DECISION MADE: 16-OCT-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
ACON LABORATORIES, INC. 510(k) NO: K012595(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 15-OCT-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
ACUSUPPLY, INC. 510(k) NO: K011247(TRADITIONAL)
ATTN: FERES DAGER PHONE NO : 305-932-9413
3801 NE 207TH STR. SUITE 501 SE DECISION MADE: 17-OCT-01
AVENTURA, FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CW DISPOSABLE ACUPUNCTURE NEEDLE
ACUSUPPLY, INC. 510(k) NO: K011248(TRADITIONAL)
ATTN: FERES DAGER PHONE NO : 305-932-9413
3801 NE 207TH STR. SUITE 501 SE DECISION MADE: 29-OCT-01
AVENTURA, FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYGENATOR
ADJUNCTIVE THERAPEUTICS, INC. 510(k) NO: K002632()
ATTN: MYRON Z BERNSTEIN PHONE NO : 301-762-0802
10 SCOTCH MIST COURT SE DECISION MADE: 25-OCT-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND TRANSDUCER COVER
ADVANCE MEDICAL DESIGNS, INC. 510(k) NO: K011265(TRADITIONAL)
ATTN: BILL GILL PHONE NO : 770-422-3125
1241 ATLANTA INDUSTRIAL DR. SE DECISION MADE: 30-OCT-01
MARIETTA, GA 30066 510(k) STATEMENT
DEVICE: ABI VEST AIRWAY CLEARANCE SYSTEM
ADVANCED RESPIRATORY 510(k) NO: K012928(TRADITIONAL)
ATTN: ERIC J LARSON PHONE NO : 651-234-1211
1020 WEST COUNTY ROAD F SE DECISION MADE: 09-OCT-01
ST. PAUL, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIPOLAR IRRIGATION FORCEPS
AESCULAP, INC. 510(k) NO: K012986(SPECIAL)
ATTN: LISA M MILLINGTON PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 03-OCT-01
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
AFP IMAGING CORP. 510(k) NO: K013176(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 16-OCT-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K012383(TRADITIONAL)
ATTN: RENEE L FLUET PHONE NO : 858-458-7563
10221 WATERIDGE CIRCLE SE DECISION MADE: 02-OCT-01
SAN DIEGO, CA 92121-2733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND
ALBERT BROWNE LTD. 510(k) NO: K012335(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 01-OCT-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
ALLIANCE MEDICAL CORP. 510(k) NO: K012625(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 22-OCT-01
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDITECH IMMUTEST DRUG SCREEN THC
AMEDITECH, INC. 510(k) NO: K011813(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, STE F SE DECISION MADE: 22-OCT-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: AMEDITECH IMMUTEST DRUG SCREEN COC
AMEDITECH, INC. 510(k) NO: K011814(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, STE F SE DECISION MADE: 22-OCT-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: PULSEMASTER ERBIUM DENTAL LASER SYSTEM
AMERICAN DENTAL TECHNOLOGIES, INC.510(k) NO: K012127(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 04-OCT-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K013355(SPECIAL)
ATTN: GINGER S GLASER PHONE NO : 952-930-6541
10700 BREN RD., WEST SE DECISION MADE: 26-OCT-01
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELIX HYDRO-JET
ANDREAS PEIN MEDIZINTECHNIK GMBH 510(k) NO: K012464(ABBREVIATED)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVENUE SE DECISION MADE: 10-OCT-01
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
ANDROMED, INC. 510(k) NO: K010729(TRADITIONAL)
ATTN: JULIA LALE AKTIK PHONE NO : 514 336 0043
4610 BOIS-FRANC ROAD SE DECISION MADE: 26-OCT-01
SAINT-LAURENT, QUEBEC, CANADA H4S 510(k) STATEMENT
DEVICE: COM-PATCH
APEX MEDICAL CORP. 510(k) NO: K012140(TRADITIONAL)
ATTN: ALAN CHANG PHONE NO : 886 226 954170
10TH FL., NO. 31, LANE 169, SE DECISION MADE: 05-OCT-01
KANG NING ST. 510(k) STATEMENT
HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: APEX MEDICAL LCD TENS-VII
APEX MEDICAL CORP. 510(k) NO: K012643(TRADITIONAL)
ATTN: ALAN CHANG PHONE NO : 886 226 954170
10TH FL., NO. 31, LANE 169, SE DECISION MADE: 29-OCT-01
KANG NING ST. 510(k) STATEMENT
HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: EPOCA CUSTOM OFFSET SHOULDER SYSTEM
ARGOMEDICAL AG 510(k) NO: K010869(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINAL STREET, STE B-210 SE DECISION MADE: 11-OCT-01
PITTSBURGH, PA 15212 510(k) STATEMENT
DEVICE: ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR "PTD"
ARROW INTL., INC. 510(k) NO: K011056(TRADITIONAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
2400 BERNVILLE RD. SE DECISION MADE: 24-OCT-01
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROB
ARROW INTL., INC. 510(k) NO: K011761(TRADITIONAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
2400 BERNVILLE RD. SE DECISION MADE: 31-OCT-01
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
ARTHREX, INC. 510(k) NO: K012923(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 04-OCT-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE ELECTROSURGERY WANDS
ARTHROCARE CORP. 510(k) NO: K012519(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 25-OCT-01
SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO-LOCK
AUTO-LOCK 510(k) NO: K010477(TRADITIONAL)
ATTN: DIETRICH W GRABIS PHONE NO : 415-454-8054
58 OAKDALE AVE. SE DECISION MADE: 09-OCT-01
SAN RAFAEL, CA 94901 510(k) STATEMENT
DEVICE: ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
BAUSCH & LOMB, INC. 510(k) NO: K012435(TRADITIONAL)
ATTN: VANADA JOHNSON PHONE NO : 636-226-3182
3365 TREE COURT INDUSTRIAL BLV SE DECISION MADE: 02-OCT-01
ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
BAYER CORP. 510(k) NO: K012340(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 01-OCT-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
BAYER CORP. 510(k) NO: K012777(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 22-OCT-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
BAYER CORP. 510(k) NO: K013272(SPECIAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 25-OCT-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
BECKMAN COULTER, INC. 510(k) NO: K012900(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 858-621-4583
1000 LAKE HAZELTINE DR. SE DECISION MADE: 16-OCT-01
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNCHRON CONTROL
BECKMAN COULTER, INC. 510(k) NO: K013235(SPECIAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 16-OCT-01
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAR MUFFINS
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K012384(TRADITIONAL)
ATTN: NORMAN E BRUNNER PHONE NO : 847-949-5200
ONE BIO-LOGIC PLAZA SE DECISION MADE: 15-OCT-01
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLATEK POWDER
BIOCORE MEDICAL TECHNOLOGIES, INC.510(k) NO: K012990(TRADITIONAL)
ATTN: AJAY KUMAR PHONE NO : 301-625-6818
11800 TECH ROAD, SE DECISION MADE: 24-OCT-01
SUITE # 240 510(k) SUMMARY AVAILABLE FROM FDA
SILVER SPRING, MD 20904-1908
DEVICE: COLLATEK SHEET
BIOCORE MEDICAL TECHNOLOGIES, INC.510(k) NO: K012995(TRADITIONAL)
ATTN: AJAY KUMAR PHONE NO : 301-625-6818
11800 TECH ROAD, SE DECISION MADE: 25-OCT-01
SUITE # 240 510(k) SUMMARY AVAILABLE FROM FDA
SILVER SPRING, MD 20904-1908
DEVICE: COLLATEK FOAM
BIOCORE MEDICAL TECHNOLOGIES, INC.510(k) NO: K012997(TRADITIONAL)
ATTN: AJAY KUMAR PHONE NO : 301-625-6818
11800 TECH ROAD, SE DECISION MADE: 25-OCT-01
SUITE # 240 510(k) SUMMARY AVAILABLE FROM FDA
SILVER SPRING, MD 20904-1908
DEVICE: COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
BIOFORM, INC. 510(k) NO: K012955(TRADITIONAL)
ATTN: VICTOR M BOWERS PHONE NO : 262-835-9800
4133 COURTNEY ROAD, #10 SE DECISION MADE: 22-OCT-01
FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
BIOLITEC, INC. 510(k) NO: K010804(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 04-OCT-01
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAL SCREW ANCHOR
BIOMET MANUFACTURING, INC. 510(k) NO: K012503(TRADITIONAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 22-OCT-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: DISCOVERY ELBOW
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K013042(SPECIAL)
ATTN: SARA B SHULTZ PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 10-OCT-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY STAT HCG TEST
BION DIAGNOSTIC SCIENCES 510(k) NO: K012559(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 425-814-1514
12277 134TH CT., N.E., #100 SE DECISION MADE: 16-OCT-01
REDMOND, WA 98052 510(k) STATEMENT
DEVICE: GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
BIONOSTICS, INC. 510(k) NO: K013147(TRADITIONAL)
ATTN: KATHY STORRO PHONE NO : 978-772-7070
7 JACKSON ROAD SE DECISION MADE: 24-OCT-01
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCUFF,C, MODELS 236018, 236028, 236036
BIONX IMPLANTS, INC. 510(k) NO: K013057(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
HERMIANKATU 6-8 L SE DECISION MADE: 12-OCT-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
BIOSITE DIAGNOSTICS 510(k) NO: K012999(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 03-OCT-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALO
BIOSITE DIAGNOSTICS 510(k) NO: K013002(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 03-OCT-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIMARK HCG COMBO PREGNANCY TEST
BIOTECH ATLANTIC, INC. 510(k) NO: K013194(SPECIAL)
ATTN: FRANCIS LEE PHONE NO : 732-389-4789
BAY F, 6 INDUSTRIAL WAY WEST SE DECISION MADE: 10-OCT-01
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
BONUTTI RESEARCH, INC. 510(k) NO: K012465(TRADITIONAL)
ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412
P.O. BOX 1367 SE DECISION MADE: 29-OCT-01
EFFINGHAM, IL 62401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 181
BOSTON SCIENTIFIC CORP. 510(k) NO: K012864(TRADITIONAL)
ATTN: JAMES D MCMAHON PHONE NO : 508-652-5566
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 24-OCT-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STEN
BOSTON SCIENTIFIC CORP. 510(k) NO: K012883(SPECIAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-650-5942
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 12-OCT-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOTOME RX MODEL # 4515, 4516
BOSTON SCIENTIFIC CORP. 510(k) NO: K013153(SPECIAL)
ATTN: LISA M QUAGLIA PHONE NO : 508-650-8267
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 19-OCT-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL
BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K012822(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 763-494-2467
ONE SCIMED PLACE SE DECISION MADE: 24-OCT-01
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VAXCEL DIALYSIS CATHETER
BOSTON SCIENTIFIC/MEDI-TECH 510(k) NO: K012948(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 03-OCT-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAF
BOSTON SCIENTIFIC/MEDI-TECH 510(k) NO: K012952(SPECIAL)
ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 02-OCT-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
BROMAC ASSISTIVE TECHNOLOGY 510(k) NO: K012345(TRADITIONAL)
ATTN: DAVID K BROWN PHONE NO : 661-264-2525
15845 SWEETAIRE AVE. SE DECISION MADE: 03-OCT-01
LANCASTER, CA 93535 510(k) STATEMENT
DEVICE: EXHALE PROBE
BRONCUS TECHNOLOGIES, INC. 510(k) NO: K013111(TRADITIONAL)
ATTN: TIMOTHY R WILLIAMS PHONE NO : 650-428-1600
1400 N SHORELINE BLVD. SE DECISION MADE: 01-OCT-01
BLDG. A, SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043 THIRD PARTY REVIEW
DEVICE: DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUA
C.R. BARD, INC. 510(k) NO: K013144(SPECIAL)
ATTN: MARION GORDON PHONE NO : 978-262-4867
129 CONCORD ROAD SE DECISION MADE: 19-OCT-01
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821
DEVICE: ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM,
CAMBRIDGE HEART, INC. 510(k) NO: K012206(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 12-OCT-01
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA CLEARBEAM PULSED DYE LASER
CANDELA CORP. 510(k) NO: K013043(TRADITIONAL)
ATTN: JOAN CLIFFORD PHONE NO : 508-358-7637
530 BOSTON POST ROAD SE DECISION MADE: 11-OCT-01
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TM2000 EASYTRACE PLUS RECEIVING CENTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K013175(SPECIAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484600
2 PEKERIS STREET SE DECISION MADE: 30-OCT-01
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C. NET 2100
CARDIONETICS, LTD. 510(k) NO: K010396(TRADITIONAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 04-OCT-01
WALTHAM,, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE X-RAY IMAGING DEVICES
CARES BUILT, INC. 510(k) NO: K003238(TRADITIONAL)
ATTN: TIMOTHY D TELYMONDE PHONE NO : 800-358-6370
75 MANCHESTER AVENUE SE DECISION MADE: 01-OCT-01
KEYPORT, NJ 07735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SALICEPT ORAL PATCH
CARRINGTON LABORATORIES, INC. 510(k) NO: K012126(TRADITIONAL)
ATTN: KENNETH M YATES PHONE NO : 972-518-1300
2001 WALNUT HILL LN. SE DECISION MADE: 03-OCT-01
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XANTALGIN CRONO
CAVEX HOLLAND B.V. 510(k) NO: K013336(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 31 235307763
PO BOX 852 SE DECISION MADE: 29-OCT-01
HAARLEM (HOLLAND), NETHERLANDS 200510(k) STATEMENT
DEVICE: CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
CBYON, INC. 510(k) NO: K012886(SPECIAL)
ATTN: KRISHNA SUDHAKARAN PHONE NO : 650-842-1800
2275 E. BAYSHORE RD SE DECISION MADE: 09-OCT-01
SUITE 101 510(k) STATEMENT
PALO ALTO, CA 94303
DEVICE: OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
CHARLES A. SMITH 510(k) NO: K012446(SPECIAL)
ATTN: CHARLES A SMITH PHONE NO : 502-969-9652
811 STARLITE DR. SE DECISION MADE: 03-OCT-01
LOUISVILLE, KY 40207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIAL HELMET
CHILDREN'S HOSPITAL 510(k) NO: K013458(TRADITIONAL)
ATTN: CONNIE FICKLIN PHONE NO : 952-946-8080
5353 WAYZATA BOULEVARD SE DECISION MADE: 29-OCT-01
MINNEAPOLIS, MN 55416-1334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
CIRCON VIDEO 510(k) NO: K012265(TRADITIONAL)
ATTN: WAYNE B STERNER PHONE NO : 805-685-5100
6500 HOLLISTER AVE. SE DECISION MADE: 17-OCT-01
SANTA BARBARA, CA 93117 510(k) STATEMENT
DEVICE: STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
COBE CARDIOVASCULAR, INC. 510(k) NO: K001509(ABBREVIATED)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 26-OCT-01
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN BACTISEAL CATHETERS
CODMAN & SHURTLEFF, INC. 510(k) NO: K003322(TRADITIONAL)
ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404
325 PARAMOUNT DR. SE DECISION MADE: 01-OCT-01
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS ROBOTIC SURGICAL SYSTEM
COMPUTER MOTION, INC. 510(k) NO: K003431(TRADITIONAL)
ATTN: DAVID THOMAS PHONE NO : 805-968-9600
130-B CREMONA DR. SE DECISION MADE: 05-OCT-01
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOCRATES ROBOTIC TELEMONITORING SYSTEM
COMPUTER MOTION, INC. 510(k) NO: K003661(TRADITIONAL)
ATTN: DAVID THOMAS PHONE NO : 805-968-9600
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 05-OCT-01
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
CONCENTRIC MEDICAL, INC. 510(k) NO: K010954(TRADITIONAL)
ATTN: KEVIN MACDONALD PHONE NO : 650-938-2100
2585 LEGHORN ST. SE DECISION MADE: 09-OCT-01
MOUTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
COOK, INC. 510(k) NO: K010016(TRADITIONAL)
ATTN: LISA HOPKINS PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 09-OCT-01
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTE
CORDIS CORP. 510(k) NO: K012993(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 305-824-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 05-OCT-01
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
CRYSTAL-SEAL DENTAL IMPLANTS 510(k) NO: K011502(TRADITIONAL)
ATTN: CLINT FOLSOM PHONE NO : 205-733-0901
181 VALLEY PARKWAY SE DECISION MADE: 22-OCT-01
PELHAM,, AL 35124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ECAT LSO PET/CT SCANNER
CTI PET SYSTEMS, INC. 510(k) NO: K013504(SPECIAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 31-OCT-01
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYCLOTEC AMT CTI TENS DEVICE
CYCLOTEC 510(k) NO: K010615(TRADITIONAL)
ATTN: STEPHEN A MICHELSON PHONE NO : 954-746-8330
4871 NORTHWEST 65TH AVE. SE DECISION MADE: 12-OCT-01
LAUDERHILL, FL 33319 510(k) STATEMENT
DEVICE: N LP(A) CONTROL SY
DADE BEHRING, INC. 510(k) NO: K013130(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 18-OCT-01
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: SNOWPOST, SNOWLIGHT
DANVILLE MATERIALS, INC. 510(k) NO: K012354(TRADITIONAL)
ATTN: CRAIG R BRUNS PHONE NO : 925-838-7940
2021 OMEGA DR. SE DECISION MADE: 10-OCT-01
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
DATA CRITICAL CORP. 510(k) NO: K013156(SPECIAL)
ATTN: TERESA DAVIDSON PHONE NO : 425-482-7047
19820 NORTH CREEK PKWY. SE DECISION MADE: 19-OCT-01
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AL-40
DDC TECHNOLOGIES, INC. 510(k) NO: K010715(TRADITIONAL)
ATTN: DMITRY DONSKOY PHONE NO : 516-770-0441
2980 WAVERLY AVE. SE DECISION MADE: 04-OCT-01
OCEANSIDE, NY 11572 510(k) STATEMENT
DEVICE: CERCON BASE
DEGUSSA - NEY DENTAL, INC. 510(k) NO: K013230(TRADITIONAL)
ATTN: THOMAS CAMERON PHONE NO : 860-242-6188
65 WEST DUDLEY TOWN RD. SE DECISION MADE: 25-OCT-01
BLOOMFIELD, CT 06002 510(k) STATEMENT
DEVICE: MARK II/MARK III MANOMETRIC PERFUSION PUMP
DENTSLEEVE PTY., LTD. 510(k) NO: K013154(SPECIAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVE. SE DECISION MADE: 19-OCT-01
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT
DENVER BIOMEDICAL, INC. 510(k) NO: K012235(SPECIAL)
ATTN: BONNIE B VIVIAN PHONE NO : 303-279-7500
14998 WEST 6TH AVE., BLDG.E700 SE DECISION MADE: 04-OCT-01
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLA SPINAL SYSTEMS
DEPUY ACROMED 510(k) NO: K012971(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 05-OCT-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH SPINAL SYSTEMS
DEPUY ACROMED 510(k) NO: K013294(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 09-OCT-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIMX SPINAL SYSTEMS
DEPUY ACROMED 510(k) NO: K013295(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 09-OCT-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSS MIAMI SPINAL SYSTEMS
DEPUY ACROMED 510(k) NO: K013296(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 09-OCT-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AML HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K012364(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 19-OCT-01
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOE
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K013134(SPECIAL)
ATTN: EDWARDS M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 15-OCT-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS,
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K013135(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 19-OCT-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K012449(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 26-OCT-01
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K012450(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 26-OCT-01
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
DIDECO 510(k) NO: K004001(ABBREVIATED)
ATTN: BARBARA WATSON PHONE NO : 303-467-6018
14401 W. 65TH WAY SE DECISION MADE: 04-OCT-01
ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULL
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K012967(SPECIAL)
ATTN: ELAD MAGAL PHONE NO : 972 9 9511511
3 HASADNOAT ST. SE DECISION MADE: 04-OCT-01
HERZLIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXAGLAZE
DMG USA, INC. 510(k) NO: K013179(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
414 SOUTH STATE STREET SE DECISION MADE: 12-OCT-01
DOVER, DE 19901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXABITE
DMG USA, INC. 510(k) NO: K013236(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 17-OCT-01
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUSBLUE
DMG USA, INC. 510(k) NO: K013237(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 22-OCT-01
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
DUTCH OPHTHALMIC USA, INC. 510(k) NO: K012821(TRADITIONAL)
ATTN: MARK W FURLONG PHONE NO : 603-642-8468
ONE LITTLE RIVER ROAD SE DECISION MADE: 22-OCT-01
P.O. BOX 968 510(k) SUMMARY AVAILABLE FROM FDA
KINGSTON, NH 03848
DEVICE: DIASUS
DYNAMIC IMAGING LTD. 510(k) NO: K013142(TRADITIONAL)
ATTN: ALLEN FINDLAY PHONE NO : 011 44 1506415282
9 COCHRANE SQUARE, SE DECISION MADE: 05-OCT-01
BRUCEFIELD INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIVINGSTON, UNITED KINGDOM EH54 9DTHIRD PARTY REVIEW
DEVICE: ATAC PAK CPK REAGENT KIT
ELAN HOLDINGS, INC. 510(k) NO: K012474(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 03-OCT-01
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANIMEC, MODELS AM-2S-4 AND AM-2S-5
ELLTEC CO., LTD. 510(k) NO: K012906(SPECIAL)
ATTN: GENSHIRO OGAWA PHONE NO : 81 52 2017308
SHIRAKAWA NO. 6 BLDG. RM. 206 SE DECISION MADE: 09-OCT-01
2-18-5, NISHIKI, NAKA-KU 510(k) STATEMENT
NAGOYA, JAPAN, JAPAN
DEVICE: PASS SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K013191(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 24-OCT-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCARE SURGICAL SYSTEM
ENDOCARE, INC. 510(k) NO: K003811(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-595-4770
7 STUDEBAKER SE DECISION MADE: 11-OCT-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXI-SITE SP02 EAR SENSOR
EPIC MEDICAL EQUIPMENT SERVICES, I510(k) NO: K012333(SPECIAL)
ATTN: KRISTA OAKES PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300 SE DECISION MADE: 17-OCT-01
PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 2013
ERBE USA, INC. 510(k) NO: K013348(SPECIAL)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400
2275 NORTHWEST PKWY., STE. 105 SE DECISION MADE: 26-OCT-01
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODE
ETHICON ENDO-SURGERY, INC. 510(k) NO: K012176(TRADITIONAL)
ATTN: RUTH A WOOD PHONE NO : 513-337-3468
4545 CREEK RD. SE DECISION MADE: 01-OCT-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK LED GOGGLES, MODEL LED-01
EXCEL TECH. LTD. 510(k) NO: K011794(TRADITIONAL)
ATTN: SONJA MARKEZ PHONE NO : 905 829 5300 X 355
2568 BRISTOL CIRCLE SE DECISION MADE: 01-OCT-01
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
EXTERNAL COUNTERPULSATION LAB 510(k) NO: K012141(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972-977-0002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 25-OCT-01
20 HATA'AS ST. 510(k) STATEMENT
KFAR SABA, ISRAEL 44425
DEVICE: FAS ENDOLUMINAL BRUSH
FAS MEDICAL LTD. 510(k) NO: K012641(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303-956-4232
PO BOX 219 SE DECISION MADE: 15-OCT-01
INDIAN HILLS, CO 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHEM-ALERT
FEMTEK,LLC. 510(k) NO: K012230(TRADITIONAL)
ATTN: JOEL S FADEN PHONE NO : 301-881-9139
11605 HITCHING POST LANE SE DECISION MADE: 09-OCT-01
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTRAN STANDING WHEELCHAIR
FENA DESIGN, INC. 510(k) NO: K011530(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 16-OCT-01
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEJET VIDEO LINK
FERRANIA S.P.A. 510(k) NO: K013395(TRADITIONAL)
ATTN: ING. MANNELLA PAOLO PHONE NO : 39 019 5224055
57 VIALE DELLA LIBERTA SE DECISION MADE: 30-OCT-01
FERRANIA, SAVONA, ITALY 17014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
FERRANIA USA, INC. 510(k) NO: K013229(TRADITIONAL)
ATTN: DOUG HALE PHONE NO : 580-774-3623
2700 EAST FRONTAGE ROAD SE DECISION MADE: 12-OCT-01
WEATHERFORD, OK 73096-6104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO ALPHA DX SYSTEM
FIRST MEDICAL, INC. 510(k) NO: K013118(SPECIAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 15-OCT-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: END EXPIRATORY FILTER, MODEL RT020
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K002839(TRADITIONAL)
ATTN: CHRIS MANDER PHONE NO : 649 574 0100
15 MAURICE PAYKEL PL., SE DECISION MADE: 04-OCT-01
EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTFLOW
FLORENCE MEDICAL LTD. 510(k) NO: K012947(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
117 AHUZAH STREET SE DECISION MADE: 02-OCT-01
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
GALIL MEDICAL LTD. 510(k) NO: K012497(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN ST.,N.W. SE DECISION MADE: 30-OCT-01
WASHINGTON, DC 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MO
GAMBRO RENAL PRODUCTS 510(k) NO: K010985(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018
10810 W. COLLINS AVE. SE DECISION MADE: 10-OCT-01
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
GAMBRO RENAL PRODUCTS 510(k) NO: K011221(TRADITIONAL)
ATTN: SUZANNE DENNIS PHONE NO : 303-541-5075
10810 W. COLLINS AVE. SE DECISION MADE: 31-OCT-01
LAKEWOOD, CO 80215 510(k) STATEMENT
DEVICE: REVOTEK LC
GC AMERICA, INC. 510(k) NO: K012542(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 16-OCT-01
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: FUJI VII CAPSULE
GC AMERICA, INC. 510(k) NO: K013198(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 29-OCT-01
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: CARDIQ FUNCTION
GE MEDICAL SYSTEM 510(k) NO: K013422(TRADITIONAL)
ATTN: STEVEN J KACHELMEYER PHONE NO : 262-785-5018
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 30-OCT-01
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADVANCED LUNG ANALYSIS-1
GENERAL ELECTRIC CO. 510(k) NO: K013381(TRADITIONAL)
ATTN: STEVEN J KACHELMEYER PHONE NO : 262-785-5018
P.O. BOX 414 SE DECISION MADE: 26-OCT-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIS/EEG MODULE
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K012466(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 01-OCT-01
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYLASINE
GENZYME CORP. 510(k) NO: K012532(TRADITIONAL)
ATTN: NANCY A IMMEL PHONE NO : 201-402-5451
1125 PLEASANT VIEW TERRANCE SE DECISION MADE: 30-OCT-01
RIDGEFIELD, NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES
GREAT GLOVE (THAILAND) CO. LTD. 510(k) NO: K013026(TRADITIONAL)
ATTN: KM LEE PHONE NO : 603 339 21992
180/3 M. 7 SRISONTHON RD. SE DECISION MADE: 15-OCT-01
T. SRISONTHON, 510(k) STATEMENT
A. THALANG, PHUKET, THAILAND 83110
DEVICE: GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
GYNECARE CENTER 510(k) NO: K012628(TRADITIONAL)
ATTN: GREGORY JONES PHONE NO : 908-218-2481
P.O. BOX 151 SE DECISION MADE: 26-OCT-01
SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: HL168W TOUCH SCREEN
HEALTH & LIFE CO., LTD. 510(k) NO: K013033(SPECIAL)
ATTN: PAUL YANG PHONE NO : 886 232 349600
6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 23-OCT-01
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN) 235
DEVICE: RAICHEM BUN RATE REAGENT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K012649(TRADITIONAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 15-OCT-01
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: RAICHEM GLUCOSE UV REAGENT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K012668(TRADITIONAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 15-OCT-01
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: SONICWAVE SONIC PLAQUE REMOVER
HOMEDICS, INC. 510(k) NO: K012914(TRADITIONAL)
ATTN: DAVID VANDERLIN PHONE NO : 248-863-3000
3000 PONTIAC TRAIL SE DECISION MADE: 01-OCT-01
COMMERCE TOWNSHIP, MI 48390 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SER
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K011916(TRADITIONAL)
ATTN: PENNY M NORTHCUTT PHONE NO : 706-846-3126
1 HORIZON WAY SE DECISION MADE: 31-OCT-01
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSAFE SAFETY SYRINGE
HOU-SE MEDICAL INC 510(k) NO: K012726(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO :
P.O. BOX 630374 SE DECISION MADE: 18-OCT-01
IRVING, TX 75063-0374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON PS LIPPED TIBIAL INSERT
HOWMEDICA OSTEONICS 510(k) NO: K012172(TRADITIONAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 10-OCT-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGUS II TRAJECTORY GUIDE
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K012366(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD SE DECISION MADE: 01-OCT-01
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: NAVIGUS II MR
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K012719(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 EAU GALLIE BLVD. SE DECISION MADE: 22-OCT-01
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: CONFORM SHEETING, MODEL IGEL
IMPLANTECH ASSOCIATES, INC. 510(k) NO: K012419(TRADITIONAL)
ATTN: STEPHEN MEADE PHONE NO : 805-339-9415
2064 EASTMAN AVE., UNIT 101 SE DECISION MADE: 24-OCT-01
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: PAM-RL
INDIVIDUAL MONITORING SYSTEMS, INC510(k) NO: K010997(TRADITIONAL)
ATTN: DAVID T KRAUSMAN PHONE NO : 410-296-7723
1055 TAYLOR AVE., SUITE 300 SE DECISION MADE: 15-OCT-01
BALTIMORE, MD 21286-8334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION CPS 2.0 ORTHOGNATHIC PLATE
INION LTD. 510(k) NO: K013039(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 05-OCT-01
TAMPERE, FINLAND FIN-33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
INNOLATEX SDN. BHD 510(k) NO: K012664(TRADITIONAL)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO 16, JALAN BULAN U5/5 SE DECISION MADE: 24-OCT-01
BANDAR PINGGIRAN SUBANG, 510(k) SUMMARY AVAILABLE FROM FDA
SHAH ALAM,SELANGOR DARUL EHSAN, MALAYSIA
DEVICE: BIOPATCH ANTIMICROBIAL DRESSING
INTEGRA LIFESCIENCES CORP. 510(k) NO: K003229(TRADITIONAL)
ATTN: WILLIAM GOELLER PHONE NO : 908-218-2651
ROUTE 22 SE DECISION MADE: 26-OCT-01
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
INTELLIGENT INSTRUMENTS PVT. LTD. 510(k) NO: K002132(TRADITIONAL)
ATTN: S.L. KAPOOR PHONE NO : 911 164 23266
202 ASHOK BHAWAN SE DECISION MADE: 18-OCT-01
93 NEHRU PLACE 510(k) SUMMARY AVAILABLE FROM FDA
NEW DELHI, INDIA
DEVICE: XTERRA GT POWER WHEELCHAIR
INVACARE CORP. 510(k) NO: K012909(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 24-OCT-01
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: VITALSAT PULSE OXIMETER, MODEL IC32000
ISLAND CRITICAL CARE CORP. 510(k) NO: K011365(TRADITIONAL)
ATTN: SEAN FLANIGAN PHONE NO : 902 569 4447
9 MYRTLE STREET SE DECISION MADE: 26-OCT-01
STRATFORD, P.E.I., CANADA C1B 1P4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHIBA NEEDLE
ISPG, INC. 510(k) NO: K012358(TRADITIONAL)
ATTN: LORETTA F LUHMAN PHONE NO : 860-355-8511
517 LITCHFIELD RD. SE DECISION MADE: 15-OCT-01
NEW MILFORD, CT 06776 510(k) STATEMENT
DEVICE: ASTRALIS 10, MODELS # 559588, 561859
IVOCLAR VIVADENT, INC. 510(k) NO: K013275(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 19-OCT-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: ASTRALIS 7, MODEL 557545
IVOCLAR VIVADENT, INC. 510(k) NO: K013277(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DRIVE SE DECISION MADE: 22-OCT-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K012482(TRADITIONAL)
ATTN: JENNIFER PORTUGAL PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 16-OCT-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
KATECHO, INC. 510(k) NO: K012404(TRADITIONAL)
ATTN: WARREN R WALTERS PHONE NO : 515-244-1212
2500 BELL AVE. SE DECISION MADE: 12-OCT-01
DES MOINES, IA 50321 510(k) STATEMENT
DEVICE: POINT 4 FLOWABLE 2
KERR DENTAL MATERIALS CENTER 510(k) NO: K013325(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 23-OCT-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP OPAQUE 2
KERR DENTAL MATERIALS CENTER 510(k) NO: K013375(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 29-OCT-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNLITELED MODEL #2810
KINETIC INSTRUMENTS, INC. 510(k) NO: K012946(TRADITIONAL)
ATTN: WILLIAM J BECKER PHONE NO : 203-743-0080
17 BERKSHIRE BLVD. SE DECISION MADE: 02-OCT-01
BETHEL, CT 06801 510(k) STATEMENT
DEVICE: MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND E
KING SYSTEMS CORP. 510(k) NO: K012485(TRADITIONAL)
ATTN: CHARLES A BURT PHONE NO : 800-642-5464
15011 HERRIMAN BLVD. SE DECISION MADE: 09-OCT-01
P.O. BOX 1138 510(k) STATEMENT
NOBLESVILLE, IN 46060
DEVICE: ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOV
KOON SENG SDN.BHD 510(k) NO: K012714(TRADITIONAL)
ATTN: LIM WENG HENG PHONE NO : 606 986 8446
BATU 4 1/2 JALAN BAKRI SE DECISION MADE: 31-OCT-01
MUAR, JOHOR, MALAYSIA 84000 510(k) STATEMENT
DEVICE: OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQ
LESLIE W. ORGAN 510(k) NO: K010202(TRADITIONAL)
ATTN: LESLIE W ORGAN PHONE NO : 843-762-4174
1837 KEMPTON RD SE DECISION MADE: 31-OCT-01
CHARLESTON, SC 29412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPRO BATTERY SYSTEM
LINVATEC CORP. 510(k) NO: K012320(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 19-OCT-01
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED 650 MAMMOGRAPHY SYSTEM
LORAD, A HOLOGIC CO. 510(k) NO: K013290(SPECIAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203-790-1188
36 APPLE RIDGE RD. SE DECISION MADE: 24-OCT-01
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACHNET CAROTIDS COIL ARRAY ASSEMBLY
MACHNET BV 510(k) NO: K012491(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 24-OCT-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE TS ANTI-ADHESION FILM
MACROPORE, INC. 510(k) NO: K012769(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 25-OCT-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIE
MASIMO CORP. 510(k) NO: K012992(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 03-OCT-01
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-ON CONDOM
MAYER LABORATORIES 510(k) NO: K001974(TRADITIONAL)
ATTN: DAVID P MAYER PHONE NO : 510-437-8989
646 KENNEDY ST., BLDG. C SE DECISION MADE: 24-OCT-01
OAKLAND, CA 94606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
MEASUREMENT SPECIALTIES, INC. 510(k) NO: K010706(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 05-OCT-01
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERCOSTAL LOCKABLE-DIRECTABLE PORT
MEDCANICA, INC. 510(k) NO: K011349(TRADITIONAL)
ATTN: CHRISTIAN L MAZZOLA PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 05-OCT-01
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRUMENT DAMPING PORT
MEDCANICA, INC. 510(k) NO: K011373(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 12-OCT-01
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP EXCELL SPLIT TIP CATHETER
MEDCOMP 510(k) NO: K010306(TRADITIONAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DRIVE SE DECISION MADE: 03-OCT-01
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM
MEDCOMP 510(k) NO: K013162(SPECIAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 19-OCT-01
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32,
MEDICAL COMPONENTS, INC. 510(k) NO: K994105(TRADITIONAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 03-OCT-01
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM,
MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K012336(SPECIAL)
ATTN: GREGORY R ALKIRE PHONE NO : 818-768-6411
12723 WENTWORTH ST. SE DECISION MADE: 03-OCT-01
ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
MEDICAL INSTRUMENTS TECHNOLOGY, IN510(k) NO: K012632(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 435-674-4010
385 NORTH 3050 EAST, SUITE B SE DECISION MADE: 26-OCT-01
ST. GEORGE, UT 84790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
MEDRAD, INC. 510(k) NO: K012950(SPECIAL)
ATTN: LORRAINE R FREDES PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 04-OCT-01
INDIANOLA, PA 15051 510(k) STATEMENT
DEVICE: BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
MEDTRONIC AVE, INC. 510(k) NO: K011080(TRADITIONAL)
ATTN: JOHN RIOLO PHONE NO : 707-541-3271
2170 NORTHPOINT PARKWAY SE DECISION MADE: 11-OCT-01
SANTA ROSA, CA 95407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, M
MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K012143(SPECIAL)
ATTN: MELISSA HARRIGER PHONE NO : 616-643-5519
620 WATSON SW SE DECISION MADE: 24-OCT-01
GRAND RAPIDS, MI 49504-6393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K010528(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 10-OCT-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFT VB SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K010930(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-344-0807
1800 PYRAMID PL. SE DECISION MADE: 24-OCT-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K012081(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-344-0807
1800 PYRAMID PL. SE DECISION MADE: 01-OCT-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013014(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 04-OCT-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENT
MENTOR CORP. 510(k) NO: K004005(TRADITIONAL)
ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304
201 MENTOR DRIVE SE DECISION MADE: 12-OCT-01
SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERTEX-PLUS REUSABLE SURGICAL DRAPE
MERCAN AB 510(k) NO: K012237(TRADITIONAL)
ATTN: JEFFERY O STULL PHONE NO : 512-288-8272
10907 WAREHAM COURT SE DECISION MADE: 15-OCT-01
AUSTIN, TX 78739 510(k) STATEMENT
DEVICE: MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
MERCAN AB 510(k) NO: K012240(TRADITIONAL)
ATTN: JEFFREY O STULL PHONE NO : 512-288-8272
10907 WAREHAM COURT SE DECISION MADE: 15-OCT-01
AUSTIN, TX 78739 510(k) STATEMENT
DEVICE: PALAMED BONE CEMENT
MERCK BIOMATERIAL GMBH 510(k) NO: K010586(TRADITIONAL)
ATTN: THOMAS KIEWITT PHONE NO : 49 615 1722004
FRANKFURTER STR. 250, SE DECISION MADE: 30-OCT-01
D-64271 510(k) SUMMARY AVAILABLE FROM FDA
DARMSTADT, GERMANY D-64271
DEVICE: TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
MERIDIAN MEDICAL TECHNOLOGIES LTD.510(k) NO: K011058(TRADITIONAL)
ATTN: RHONA LOVE PHONE NO : 442 890 222333
207 AIRPORT RD., WEST SE DECISION MADE: 23-OCT-01
BELFAST, IRELAND BT3 9ED 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONICATOR PLUS 930, MODEL ME 930
METTLER ELECTRONICS CORP. 510(k) NO: K013192(ABBREVIATED)
ATTN: ROBERT E FLEMING PHONE NO : 714-533-2221
1333 SOUTH CLAUDINA ST. SE DECISION MADE: 17-OCT-01
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
MICRA INSTRUMENTS 510(k) NO: K011392(TRADITIONAL)
ATTN: JOHN A.K. BASKERVILLE PHONE NO : 44 158 2487104
52 BILTON WAY, SE DECISION MADE: 22-OCT-01
LUTON, BEDFORDSHIRE, UNITED KINGDO510(k) STATEMENT
DEVICE: DRUGS OF ABUSE MULTI-TEST STRIP
MICRODIAGNOSTICS, INC. 510(k) NO: K011952(TRADITIONAL)
ATTN: JUNE SHOZI PHONE NO : 949-347-0307
28062 FORBES ROAD, SUITE B SE DECISION MADE: 25-OCT-01
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: MICROMEDICS FIBRIJET AEROSOL APPLICATOR
MICROMEDICS, INC. 510(k) NO: K012868(TRADITIONAL)
ATTN: CHARLES GROTE PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR., SE DECISION MADE: 29-OCT-01
#150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: VENODYNE DVT ADVANTAGE PLUS
MICROTEK MEDICAL, INC. 510(k) NO: K011318(TRADITIONAL)
ATTN: TOM BONNER PHONE NO : 662-327-1863
512 LEHMBERG RD. SE DECISION MADE: 25-OCT-01
COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEM
MICROVENTION, INC. 510(k) NO: K012145(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
72 ARGONAUT SE DECISION MADE: 29-OCT-01
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRH-63-8 HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K013159(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 16-OCT-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HAC-420 HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K013322(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 16-OCT-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
NATIONAL CUSTOM ENT., INC. 510(k) NO: K012263(TRADITIONAL)
ATTN: DON PELLETIER PHONE NO : 952-890-1360
1133 EAST CLIFF RD. SE DECISION MADE: 10-OCT-01
BURNSVILLE, MN 55337 510(k) STATEMENT
DEVICE: MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
NATIONAL CUSTOM ENT., INC. 510(k) NO: K012264(TRADITIONAL)
ATTN: DON PELLETIER PHONE NO : 952-890-1360
1133 EAST CLIFF RD. SE DECISION MADE: 10-OCT-01
BURNSVILLE, MN 55337 510(k) STATEMENT
DEVICE: WAVELENGTH MULT-PURPOSE ULTRASOUND GEL
NATIONAL THERAPY PRODUCTS INC. 510(k) NO: K012522(TRADITIONAL)
ATTN: PAUL L HOOEY PHONE NO : 905 264 5600
2-191 ROWNTREE DAIRY RD. SE DECISION MADE: 18-OCT-01
WOODBRIDGE, ONTARIO, CANADA LHL 8B510(k) STATEMENT
DEVICE: ALGO 3 NEWBORN HEARING SCREENER
NATUS MEDICAL, INC. 510(k) NO: K013137(SPECIAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-802-0400
1501 INDUSTRIAL RD. SE DECISION MADE: 16-OCT-01
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH VARIZOOM
NEW STAR LASERS, INC. 510(k) NO: K012982(SPECIAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 02-OCT-01
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K012367(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-240-5260
33047 CALLE AVIADOR SE DECISION MADE: 09-OCT-01
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFOSCAN 2 CONFOCAL MICROSCOPE
NIDEK TECHNOLOGIES SRL 510(k) NO: K012416(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 26-OCT-01
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMI-FLOW, MODEL 6-850-00/ 01/02
NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K010053(TRADITIONAL)
ATTN: CASEY KUREK PHONE NO : 847-608-8900
600 CHURCH RD. SE DECISION MADE: 23-OCT-01
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MU PHOTONICS PAIN THERAPIST
NU PHOTONICS, INC. 510(k) NO: K012508(TRADITIONAL)
ATTN: WILLIAM M BROCK PHONE NO : 303-922-9200
666 BRYANT STREET SE DECISION MADE: 09-OCT-01
DENVER, CO 80204 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SEED SELECTRON MODEL V. 1.0
NUCLETRON CORP. 510(k) NO: K010032(TRADITIONAL)
ATTN: RALPH E SHUPING PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 17-OCT-01
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
NUVASIVE, INC. 510(k) NO: K013215(SPECIAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
10065 OLD GROVE RD SE DECISION MADE: 16-OCT-01
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMI-ARC SURGICAL NAVIGATOR
NUVASIVE, INC. 510(k) NO: K013257(SPECIAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-271-7070
10065 OLD GROVE RD. SE DECISION MADE: 30-OCT-01
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
NXSTAGE MEDICAL, INC. 510(k) NO: K012510(SPECIAL)
ATTN: KAREN ST.ONGE PHONE NO : 978-687-4700
439 SOUTH UNION STREET SE DECISION MADE: 19-OCT-01
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
S. LAWRENCE, MA 01843
DEVICE: COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DI
NXSTAGE MEDICAL, INC. 510(k) NO: K012832(TRADITIONAL)
ATTN: KAREN ST. ONGE PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 24-OCT-01
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN-2200, MODEL 1
OCEANIC MEDICAL PRODUCTS, INC. 510(k) NO: K010613(TRADITIONAL)
ATTN: WILLIAM M GATES PHONE NO : 913-874-2000
8005 SHANNON INDUSTRIAL PARK SE DECISION MADE: 12-OCT-01
LN. 510(k) SUMMARY AVAILABLE FROM FDA
ATCHISON, KS 66002
DEVICE: BIOMEDICS UV MULTIFOCAL
OCULAR SCIENCES PUERTO RICO, INC. 510(k) NO: K012425(TRADITIONAL)
ATTN: RICHARD LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 12-OCT-01
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED
OMNIGRACE (THAILAND) LTD. 510(k) NO: K012402(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-305-0185
7815 VANDERBILT DRIVE NW SE DECISION MADE: 12-OCT-01
NORTH CANTON, OH 44720 510(k) STATEMENT
DEVICE: MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
ONCOLOGY DATA SYSTEMS, INC. 510(k) NO: K012227(TRADITIONAL)
ATTN: GREGORY G MILLER PHONE NO : 405-691-2770
12401 S. RIVERVIEW ROAD SE DECISION MADE: 01-OCT-01
OKLAHOMA CITY, OK 73173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VBR
OSTEOTECH, INC. 510(k) NO: K012254(TRADITIONAL)
ATTN: KIM THURMAN PHONE NO : 732-544-6231
51 JAMES WAY SE DECISION MADE: 16-OCT-01
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOSERIGHT
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K012238(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-926-7674
710 BRIDGEPORT AVE. SE DECISION MADE: 01-OCT-01
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING
PHOENIX DIAGNOSTICS, INC. 510(k) NO: K012509(TRADITIONAL)
ATTN: RAM NUNNA PHONE NO : 508-655-8310
8 TECH CIRCLE SE DECISION MADE: 09-OCT-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAAS II QVA
PIE MEDICAL IMAGING B.V. 510(k) NO: K012475(TRADITIONAL)
ATTN: CARLA DE VRIES PHONE NO : 314 332 81322
BECANUSSTRAAT 13 D SE DECISION MADE: 24-OCT-01
MAASTRICHT, NETHERLANDS 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K013173(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 22-OCT-01
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K012809(TRADITIONAL)
ATTN: LAURENCE A POTTER PHONE NO : 215-862-4450
4 B EAST BRIDGE ST. SE DECISION MADE: 26-OCT-01
NEW HOPE, PA 18938 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE QUIET SLEEPER
PRECISION DENTAL LABORATORIES, INC510(k) NO: K012142(TRADITIONAL)
ATTN: SHARON LAMONT PHONE NO : 701-280-9089
6 BROADWAY SUITE 200 SE DECISION MADE: 04-OCT-01
FARGO, ND 58102 510(k) STATEMENT
DEVICE: PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K012673(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 24-OCT-01
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: ALWAYS DUETS
PROCTER & GAMBLE CO. 510(k) NO: K012629(TRADITIONAL)
ATTN: MARK M ANDERSON PHONE NO : 513-634-5196
6110 CENTER HILL AVE. SE DECISION MADE: 05-OCT-01
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN
QINGDAO BESTEX RUBBER & PLASTIC PR510(k) NO: K012709(TRADITIONAL)
ATTN: ZECHUAN SHAO PHONE NO : 408-980-1348
2576 LAFAYETTE STREET SE DECISION MADE: 01-OCT-01
SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVEEN ELECTRODE
RADIOTHERAPEUTICS CORP. 510(k) NO: K012315(TRADITIONAL)
ATTN: KIRSTEN VALLEY PHONE NO : 408-745-3200
1308 BORREGAS AVE.SUITE 200 SE DECISION MADE: 11-OCT-01
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOPULSE, MODEL 100
REVIVANT CORP. 510(k) NO: K011046(TRADITIONAL)
ATTN: BOB KATZ PHONE NO : 408-524-3500
775 PALOMAR SE DECISION MADE: 25-OCT-01
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHODIA DENTAL PUTTY IMPRESSION MATERIAL
RHODIA INC. 510(k) NO: K013129(TRADITIONAL)
ATTN: ALAIN MORIN PHONE NO : 805-653-5638
320 W. STANLEY AVE SE DECISION MADE: 10-OCT-01
VENTURA, CA 93001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
RHODIA INC. 510(k) NO: K013140(TRADITIONAL)
ATTN: ALAIN MORIN PHONE NO : 805-653-5638
320 W. STANLEY AVE SE DECISION MADE: 10-OCT-01
VENTURA, CA 93001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WINNER CM4 COMBINATION UNIT
RICH-MAR CORP. 510(k) NO: K012848(TRADITIONAL)
ATTN: DAVID RICHARDS PHONE NO : 918-543-2222
P.O. BOX 879 SE DECISION MADE: 25-OCT-01
INOLA, OK 74036 510(k) STATEMENT
DEVICE: RIWO SYSTEM TRAYS
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K012309(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 19-OCT-01
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECUREGUARD RETRACTABLE SAFETY SYRINGE
SAFEGARD MEDICAL PRODUCTS, INC. 510(k) NO: K012121(TRADITIONAL)
ATTN: MIKE DAYTON PHONE NO : 813-949-6090
14802 HADLEIGH WAY SE DECISION MADE: 24-OCT-01
TAMPA, FL 33624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
SAFEGARD MEDICAL PRODUCTS, INC. 510(k) NO: K012283(TRADITIONAL)
ATTN: PATRICK GRANT, JR. PHONE NO : 978-256-0906
52 DRAGON CT. SE DECISION MADE: 01-OCT-01
WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SDI SB OFFICE, MODEL 29-
SDI DIAGNOSTICS, INC. 510(k) NO: K011470(TRADITIONAL)
ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033
10 HAMPDEN DR. SE DECISION MADE: 12-OCT-01
EASTON, MA 02375 510(k) STATEMENT
DEVICE: THECURVE, ITEM 507
SELECT MEDICAL SYSTEMS, INC. 510(k) NO: K012935(TRADITIONAL)
ATTN: MONIQUE GIRARD PHONE NO : 802-862-1017
P.O. BOX 966 SE DECISION MADE: 11-OCT-01
WILLISTON, VT 05495-0966 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
SHAMROCK MANUFACTURING COMPANY 510(k) NO: K012786(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 626-913-1798
889 S. AZUSA AVE. SE DECISION MADE: 01-OCT-01
CITY OF INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLO
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K012339(TRADITIONAL)
ATTN: JOHN LAI PHONE NO : 862 157 814213
259 YUSHU RD., SE DECISION MADE: 16-OCT-01
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA 201600
DEVICE: ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K012499(TRADITIONAL)
ATTN: JOHN LAI PHONE NO : 011 862 157814213
259 YUSHU RD., SE DECISION MADE: 16-OCT-01
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA 201600
DEVICE: CTS-485 ULTRASOUND IMAGING SYSTEM
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K012772(TRADITIONAL)
ATTN: ROBERT MORTON PHONE NO : 925-210-0715
1106 CHILTERN DRIVE SE DECISION MADE: 01-OCT-01
WALNUT CREEK, CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
SHIJIAZHUANG BRILLIANCE PLASTIC CO510(k) NO: K012710(TRADITIONAL)
ATTN: HUAN CHUNG-LI PHONE NO : 978-436-9980
17A STERLING ROAD SE DECISION MADE: 04-OCT-01
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
SHIMADZU CORP. 510(k) NO: K012424(TRADITIONAL)
ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVENUE SE DECISION MADE: 18-OCT-01
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SOVEREIGN
SHOPRIDER INTL., INC. 510(k) NO: K011476(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
P.O. BOX 187 SE DECISION MADE: 30-OCT-01
NEODESHA, KS 66757 510(k) STATEMENT
DEVICE: OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K012495(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 31-OCT-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MT ALERT INFUSION MONITOR
SIERRA BIOSEARCH INC 510(k) NO: K013121(TRADITIONAL)
ATTN: RICHARD CITRENAUM PHONE NO : 760-872-4690
395 MT. TOM RD. SE DECISION MADE: 15-OCT-01
BISHOP, CA 93514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY HBA KIT, MODELS 537-A, 537-B
SIGMA DIAGNOSTICS, INC. 510(k) NO: K012410(TRADITIONAL)
ATTN: WILLIAM R GILBERT II PHONE NO : 314-286-6693
545 SOUTH EWING AVE. SE DECISION MADE: 26-OCT-01
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTI
SODEM SYSTEMS 510(k) NO: K012453(TRADITIONAL)
ATTN: CAROLE BURNIER PHONE NO : 41 22 7949696
110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 22-OCT-01
GENEVA, SWITZERLAND CH-1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
SODEM SYSTEMS 510(k) NO: K012457(TRADITIONAL)
ATTN: CAROLE BURNIER PHONE NO : 41 22 7949696
110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 22-OCT-01
GENEVA, SWITZERLAND CH-1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETEX SUP PUBOURETHRAL SLING
SOFRADIM PRODUCTION 510(k) NO: K012949(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 04-OCT-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NU-SPEC D
SOL WEISS MD INC 510(k) NO: K012859(TRADITIONAL)
ATTN: SOL WEISS PHONE NO : 818-346-1515
7012 RESEDA BOULEVARD SE DECISION MADE: 26-OCT-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
RESEDA, CA 91335
DEVICE: SOPRO595 INTRA ORAL CAMERA
SOPRO 510(k) NO: K012505(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 334 912 70727
PLACE ST. CHRISTOPHE SE DECISION MADE: 05-OCT-01
LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE F-13011
DEVICE: ICE
SOUTHERN DENTAL INDUSTRIES, LTD. 510(k) NO: K012528(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 22-OCT-01
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: ROK
SOUTHERN DENTAL INDUSTRIES, LTD. 510(k) NO: K012529(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 22-OCT-01
BENSENVILLE, IL 60106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
SPECIALITES SEPTODONT 510(k) NO: K012427(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378
1050 CONNECTICUT AVE. NW SE DECISION MADE: 09-OCT-01
WASHINGTON, DC 20036-5339 510(k) STATEMENT
DEVICE: SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
ST. JUDE MEDICAL 510(k) NO: K013029(SPECIAL)
ATTN: JIM M TAUFEN PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 09-OCT-01
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: COMPEL SURGICAL DRAPES
STANDARD TEXTILE CO., INC. 510(k) NO: K012807(SPECIAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 11-OCT-01
CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SE
STERILMED, INC. 510(k) NO: K003857(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 763-519-9155
3650 ANNAPOLIS LANE NORTH SE DECISION MADE: 18-OCT-01
SUITE 170 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES
STERLING MEDIVATIONS, INC. 510(k) NO: K013104(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 02-OCT-01
LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO A620 EEG
STOELTING CO. 510(k) NO: K012011(SPECIAL)
ATTN: KENNETH L BIRD PHONE NO : 630-860-9700
620 WHEAT LN. SE DECISION MADE: 10-OCT-01
WOOD DALE, IL 60191 510(k) STATEMENT
DEVICE: STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
STONY BROOK SURGICAL INNOVATIONS, 510(k) NO: K013059(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 22-OCT-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K012961(SPECIAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9900
9900 SPECTRUM DR. SE DECISION MADE: 18-OCT-01
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
SUN-RAIN SYSTEM CORP. 510(k) NO: K011913(TRADITIONAL)
ATTN: YANG TIEN-HISING PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 26-OCT-01
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: LIFE 2
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K012717(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 25-OCT-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP ENAMEL 2
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013007(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 01-OCT-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS 2 MODIFIED
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013008(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 02-OCT-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013009(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 03-OCT-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
TERUMO MEDICAL CORP. 510(k) NO: K013164(SPECIAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241
125 BLUE BALL ROAD SE DECISION MADE: 15-OCT-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
THE KENDALL COMPANY 510(k) NO: K011283(TRADITIONAL)
ATTN: DAVID A OLSON PHONE NO : 508-261-0530
15 HAMPSHIRE STREET SE DECISION MADE: 15-OCT-01
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODE
THE LUDLOW COMPANY LP 510(k) NO: K012218(TRADITIONAL)
ATTN: KATHLEEN M TREMBLAY PHONE NO : 413-493-8288
TWO LUDLOW PARK DR. SE DECISION MADE: 12-OCT-01
CHICOPEE, MA 01022 510(k) STATEMENT
DEVICE: THEKEN SMALL CEMENT RESTRICTOR
THEKEN SURGICAL,LLC 510(k) NO: K012278(TRADITIONAL)
ATTN: RANDY THEKEN PHONE NO : 330-753-7451
1100 NOLA AVE. SE DECISION MADE: 17-OCT-01
BARBETON, OH 44203-3819 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEKEN LARGE CEMENT RESTRICTOR
THEKEN SURGICAL,LLC 510(k) NO: K012462(TRADITIONAL)
ATTN: RANDY THEKEN PHONE NO : 330-753-7451
1100 NOLA AVE. SE DECISION MADE: 29-OCT-01
BARBETON, OH 44203-3819 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: THERMACOOL IIA
THERMAGE, INC. 510(k) NO: K013034(SPECIAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7120
4058 POINT EDEN WAY SE DECISION MADE: 04-OCT-01
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR
THERMO DMA, INC. 510(k) NO: K012518(ABBREVIATED)
ATTN: THOMAS DOLLAR PHONE NO : 817-607-1700
845 AVE. G EAST SE DECISION MADE: 09-OCT-01
ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
THERMO DMA, INC. 510(k) NO: K012525(ABBREVIATED)
ATTN: THOMAS DOLLAR PHONE NO : 817-607-1700
845 AVE. G EAST SE DECISION MADE: 04-OCT-01
ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
THERMO DMA, INC. 510(k) NO: K012878(ABBREVIATED)
ATTN: THOMAS DOLLAR PHONE NO : 817-607-1700
845 AVE. G EAST SE DECISION MADE: 16-OCT-01
ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BRAIDED GUIDING INTRODUCER
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K013202(SPECIAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 23-OCT-01
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSFET AUTOSENSE, MODEL TN-RD-60
THOMSON & NIELSEN ELECTRONICS, LTD510(k) NO: K013279(SPECIAL)
ATTN: NORMA THOMSON PHONE NO : 613 596 4563
25-B NORTHSIDE RD. SE DECISION MADE: 18-OCT-01
NEPEAN, ONTARIO, CANADA K2H 8S1 510(k) STATEMENT
DEVICE: TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATIO
TILLOTSON HEALTHCARE CORP. 510(k) NO: K013016(TRADITIONAL)
ATTN: F. W PERRELLA PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 19-OCT-01
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINA
TILLOTSON HEALTHCARE CORP. 510(k) NO: K013286(TRADITIONAL)
ATTN: THOMAS N TILLOTSON PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 12-OCT-01
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TORAYSULFONE DIALYZER
TORAY INDUSTRIES (AMERICA), INC. 510(k) NO: K002512(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775
540 COLLEGE STREET SE DECISION MADE: 15-OCT-01
BELLAIRE, TX 77401-5010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K013214(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 05-OCT-01
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K012895(TRADITIONAL)
ATTN: CYNTHIA C KAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 30-OCT-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K991810(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 09-OCT-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: MONOJECT SAFETY NEEDLE
TYCO HEALTHCARE 510(k) NO: K012736(TRADITIONAL)
ATTN: DAVID A OLSON PHONE NO : 508-261-8000
15 HAMPSHIRE STREET SE DECISION MADE: 25-OCT-01
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYTRAVEL
TZORA ACTIVE SYSTEMS LTD. 510(k) NO: K012592(TRADITIONAL)
ATTN: YOEL ETZIONI PHONE NO :
SE DECISION MADE: 03-OCT-01
510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MR-GUIDE 2000
ULTRAGUIDE LTD. 510(k) NO: K013150(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 18-OCT-01
HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTOFLEX
UNICARE BIOMEDICAL, INC. 510(k) NO: K012144(TRADITIONAL)
ATTN: STAN YANG PHONE NO : 949-643-6707
25951 LA CUESTA AVE. SE DECISION MADE: 01-OCT-01
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED ARTHROSCOPIC BLADES
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012346(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 16-OCT-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED COMPRESSION GARMENT
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012403(TRADITIONAL)
ATTN: MICHAEL SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 17-OCT-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED ARTHROSCOPIC WANDS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012695(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 30-OCT-01
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESSSUITE
VIDAR SYSTEMS CORP. 510(k) NO: K011049(TRADITIONAL)
ATTN: MARY HARP PHONE NO : 703-471-7070
460 SPRING PARK PL. SE DECISION MADE: 01-OCT-01
HERNDON, VA 20170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-1
VSM TECHNOLOGY, INC. 510(k) NO: K012636(TRADITIONAL)
ATTN: DARYL WISDAHL PHONE NO : 604 941 8561
675 WEST HASTING ST., 15TH FL. SE DECISION MADE: 26-OCT-01
VANCOUVER, B.C., CANADA V6B 1N2 510(k) STATEMENT
DEVICE: GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K013250(SPECIAL)
ATTN: TIMOTHY J RYNN PHONE NO : 928-864-3714
3450 WEST KILTIE LANE SE DECISION MADE: 26-OCT-01
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
WALTER LORENZ SURGICAL, INC. 510(k) NO: K012409(TRADITIONAL)
ATTN: SHERYL MALMBERG PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 18-OCT-01
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER MODEL # HS-320
WAREPALMY ENTERPRISE LLC (USA) 510(k) NO: K012791(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 EAST COLUMBINE DRIVE SE DECISION MADE: 24-OCT-01
PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBITIY SCOOTER MODEL #HS-360
WAREPALMY ENTERPRISE LLC (USA) 510(k) NO: K012792(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 EAST COLUMBINE DRIVE SE DECISION MADE: 24-OCT-01
PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERO50, ORDER-NO.: 2070
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012838(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 23-OCT-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EURO 45, ORDER-NO.: 2064
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012840(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 23-OCT-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. CREATININA CINETICA AA
WIENER LABORATORIES S.A.I.C. 510(k) NO: K012065(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 841982
2944 RIOBAMBA SE DECISION MADE: 10-OCT-01
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK ULTRASOUND BIOPSY NEEDLE
WILSON-COOK MEDICAL, INC. 510(k) NO: K013356(SPECIAL)
ATTN: MARGARET J POSNER PHONE NO : 336-744-0157
4900 BETHANIA STATION ROAD SE DECISION MADE: 19-OCT-01
WINSTON-SALEM, NC 27106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOSET BVF KIT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K010532(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 26-OCT-01
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-FEMUR
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K012091(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-9971
5677 AIRLINE RD. SE DECISION MADE: 03-OCT-01
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PR
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K012876(TRADITIONAL)
ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 603 870 69788
LOT 11, JALAN 2, KAWASAN SE DECISION MADE: 01-OCT-01
PERUSAHAAN BANDAR BARU, SALAK 510(k) SUMMARY AVAILABLE FROM FDA
TINGGI, SEPANG, SELANGOR, MALAYSIA 43900
DEVICE: LASER 20
YA-MAN LTD 510(k) NO: K011021(TRADITIONAL)
ATTN: ROBERT T HANDREN PHONE NO : 352-314-8829
5818 PRINCESS CAROLINE PLACE SE DECISION MADE: 09-OCT-01
LEESBURG, FL 34748 510(k) STATEMENT
DEVICE: MODIFICATION TO FLOUROLAB PLUS
Z-KAT, INC. 510(k) NO: K013025(SPECIAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2903 SIMMS STREET SE DECISION MADE: 03-OCT-01
HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 299
TOTAL WITH SUMMARIES 231
TOTAL WITH STATEMENTS 68
Updated 5/28/2002
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