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510(k)s Final Decisions Rendered for October 2001 |
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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