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510(k)s Final Decisions Rendered for July 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-JUL-2001 THROUGH 31-JUL-2001
DEVICE: TACKER, MODEL R65-933
A & A MEDICAL, INC. 510(k) NO: K003949(TRADITIONAL)
ATTN: JIHAD MANSOUR PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE SE DECISION MADE: 25-JUL-01
ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MMODIFICATION TO LAMINARIA
A & A MEDICAL, INC. 510(k) NO: K011512(TRADITIONAL)
ATTN: JIHAD (JAY) MANSOUR PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE SE DECISION MADE: 09-JUL-01
ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
A & D ENGINEERING, INC. 510(k) NO: K012013(TRADITIONAL)
ATTN: JERRY WANG PHONE NO : 408-263-5333
1555 MC CANDLESS DR. SE DECISION MADE: 13-JUL-01
MILPITAS, CA 95035 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE
ACON LABORATORIES, INC. 510(k) NO: K010841(TRADITIONAL)
ATTN: ROBERT HUDAK PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD SE DECISION MADE: 09-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES
ACON LABORATORIES, INC. 510(k) NO: K011353(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4104 SORRENTO VALLY BLVD. SE DECISION MADE: 30-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STE
ACON LABORATORIES, INC. 510(k) NO: K011672(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 31-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPH
ACON LABORATORIES, INC. 510(k) NO: K011673(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 31-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIADUCT MICROENDOSCOPE AND ACCESSORIES
ACUEITY, INC. 510(k) NO: K011189(TRADITIONAL)
ATTN: MARYBETH FECTEAU PHONE NO : 508-987-6612
15 INDUSTRIAL PARK EAST SE DECISION MADE: 16-JUL-01
OXFORD, MA 01540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL DRAPES
ADVANCE MEDICAL DESIGNS, INC. 510(k) NO: K011422(TRADITIONAL)
ATTN: BILL GILL PHONE NO : 770-422-3125
1241 ATLANTA INDUSTRIAL DR. SE DECISION MADE: 10-JUL-01
MARIETTA, GA 30066 510(k) STATEMENT
DEVICE: SCALPFIX CLIP SYSTEM
AESCULAP, INC. 510(k) NO: K012219(SPECIAL)
ATTN: LISA M MILLINGTON PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 31-JUL-01
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILENT M2636B TELEMON B MONITOR (TELEMON B)
AGILENT TECHNOLOGIES, INC. 510(k) NO: K011824(SPECIAL)
ATTN: DENISE HALEY PHONE NO : 978-659-2701
3000 MINUTEMAN RD. SE DECISION MADE: 02-JUL-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K012094(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD., MS 0491 SE DECISION MADE: 20-JUL-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLEABLE SHAFT CLAMP
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K011078(SPECIAL)
ATTN: LANCE MARCONI PHONE NO : 847-785-3312
1500 WAUKEGAN RD. SE DECISION MADE: 13-JUL-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID DRUG SCREEN
AMERICAN BIO MEDICA CORP. 510(k) NO: K012159(SPECIAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 25-JUL-01
BEVERLY, MA 01915 510(k) STATEMENT
DEVICE: IN-FAST BONE SCREW SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K011910(SPECIAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6309
10700 BREN RD., WEST SE DECISION MADE: 13-JUL-01
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMERITEK BRACHYTHERAPY TEMPLATE
AMERTEK MEDICAL, INC. 510(k) NO: K011581(TRADITIONAL)
ATTN: GREG WIITA PHONE NO : 561-842-7595
2655 NORTH OCEAN DRIVE SE DECISION MADE: 17-JUL-01
SINGER ISLAND, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIGO WHEELCHAIR
AMIGO MOBILITY INTL., INC. 510(k) NO: K010503(TRADITIONAL)
ATTN: MIKE LABRAKE PHONE NO : 517-777-0910
6693 DIXIE HWY. SE DECISION MADE: 06-JUL-01
BRIDGEPORT, MI 48722 510(k) STATEMENT
DEVICE: MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V
APEX MEDICAL CORP. 510(k) NO: K002336(TRADITIONAL)
ATTN: DANIEL LEE PHONE NO : 886 226 954122
10TH FL., NO. 31, LANE 169, SE DECISION MADE: 27-JUL-01
KANG NING ST. 510(k) SUMMARY AVAILABLE FROM FDA
HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: UROLOGICAL CATHETER
APOGEE MEDICAL, INC. 510(k) NO: K011552(TRADITIONAL)
ATTN: BRENT D ROBLING PHONE NO : 919-570-9605
90 WEATHERS ST. SE DECISION MADE: 18-JUL-01
YOUNGSVILLE, NC 27549 510(k) STATEMENT
DEVICE: SURESTEP FSH MENOPAUSE TEST
APPLIED BIOTECH, INC. 510(k) NO: K010556(TRADITIONAL)
ATTN: DAVE D SMITH PHONE NO : 858-713-9614
10237 FLANDERS CT. SE DECISION MADE: 09-JUL-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: DRAINAGE CATHETER OR FOLEY CATHETER
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K010006(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 25-JUL-01
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESH URETERAL STENT
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K011264(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 17-JUL-01
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMOBILIZATION SYSTEM FOR ENT
ARPLAY MEDICAL S.A. 510(k) NO: K003779(TRADITIONAL)
ATTN: RICHARD BORGI PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX SE DECISION MADE: 12-JUL-01
IZEURE, COTE D'OR, FRANCE 21110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTEC EVAC PLASMA WAND
ARTHROCARE CORP. 510(k) NO: K011279(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 19-JUL-01
SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
ASIA-MED GMBH AND CO KG 510(k) NO: K011808(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 10-JUL-01
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: BIS ENGINE
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K011834(SPECIAL)
ATTN: CHRISTINE M VOZELLA PHONE NO : 617-559-7400
141 NEEDHAM STREET SE DECISION MADE: 10-JUL-01
NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
AVID CARE CORP. 510(k) NO: K011779(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 13-JUL-01
WASHINGTON, DC 20004-1109 510(k) STATEMENT
DEVICE: PROVIEW EYE PRESSURE MONITOR
BAUSCH & LOMB, INC. 510(k) NO: K011199(TRADITIONAL)
ATTN: DOUGLAS J FORTUNATO PHONE NO : 716-338-5477
1400 N.GOODMAN STREET SE DECISION MADE: 02-JUL-01
ROCHESTER, NY 14692-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILI
BAUSCH & LOMB, INC. 510(k) NO: K011718(TRADITIONAL)
ATTN: DEBRA KETCHUM PHONE NO : 716-338-8638
1400 NORTH GOODMAN STREET SE DECISION MADE: 25-JUL-01
P.O. BOX 450 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14692
DEVICE: BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
BAYER CORP. 510(k) NO: K010668(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 05-JUL-01
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
BD 510(k) NO: K011982(SPECIAL)
ATTN: GREGORY W MORGAN PHONE NO : 201-847-4344
ONE BECTON DRIVE MC226 SE DECISION MADE: 17-JUL-01
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
BECKMAN COULTER, INC. 510(k) NO: K010748(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 10-JUL-01
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
BECKMAN COULTER, INC. 510(k) NO: K011342(TRADITIONAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 09-JUL-01
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SO
BESCON CO., LTD. 510(k) NO: K001962(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 09-JUL-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT
BESCON CO., LTD. 510(k) NO: K002099(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 09-JUL-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E
BIO-RAD LABORATORIES 510(k) NO: K011853(TRADITIONAL)
ATTN: DONNA CHAPMAN PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 17-JUL-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700
BIO-RAD LABORATORIES 510(k) NO: K011867(TRADITIONAL)
ATTN: DONNA CHAPMAN PHONE NO : 949-598-1200
9500 JERONIMO ROAD SE DECISION MADE: 12-JUL-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY
BIOCHECK, INC. 510(k) NO: K003851(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 20-JUL-01
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
BIOCOMPOSITES LTD. 510(k) NO: K003954(TRADITIONAL)
ATTN: J. STEPHEN BRATT PHONE NO : 441 782 206500
ETRUSCAN STREET SE DECISION MADE: 12-JUL-01
ETRURIA 510(k) SUMMARY AVAILABLE FROM FDA
STOKE ON TRENT, STAFFORDSHIRE, UNITED KINGDOM ST1 5PQ
DEVICE: GASTRIC SUCTION AND DRAINAGE CATHETER
BIOENTERICS CORP. 510(k) NO: K002838(TRADITIONAL)
ATTN: DAVID MUNJAL PHONE NO : 805-684-3045
1035 CINDY LN. SE DECISION MADE: 09-JUL-01
CARPINTERIA, CA 93013 510(k) STATEMENT
DEVICE: WATERLASE, MILLENNIUM
BIOLASE TECHNOLOGY, INC. 510(k) NO: K011041(TRADITIONAL)
ATTN: IOANA M RIZOIU PHONE NO : 949-361-0204
981 CALLE AMANECER SE DECISION MADE: 03-JUL-01
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2A ACETABULAR SYSTEM
BIOMET, INC. 510(k) NO: K011110(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 02-JUL-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
BIOMET, INC. 510(k) NO: K011138(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 10-JUL-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
BIOMET, INC. 510(k) NO: K011455(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-JUL-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: RESORBABLE BONE PINS
BIOMET, INC. 510(k) NO: K011522(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 31-JUL-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: COLOR BUFFED (CB) DDH FEMORAL STEM
BIOMET, INC. 510(k) NO: K012019(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 20-JUL-01
WARSAW, IN 46582-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVC FREE INTRAVASCULAR ADMINISTRATION SET
BIOMETRIX LTD. 510(k) NO: K011216(TRADITIONAL)
ATTN: MIRIAM ABUTBUL PHONE NO : 972 2 5861241
4 KIRYAT MADA, SE DECISION MADE: 18-JUL-01
P.O. BOX 45057 510(k) STATEMENT
JERUSALEM, ISRAEL 91450
DEVICE: 1.5MM BONE FIXATION KIT
BIONX IMPLANTS, LTD. 510(k) NO: K012000(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 18-JUL-01
HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: SMARTSCREW
BIONX IMPLANTS, LTD. 510(k) NO: K012001(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 18-JUL-01
HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION A
BIOSAFE LABORATORIES, INC. 510(k) NO: K011525(TRADITIONAL)
ATTN: LAURIE A WATERS PHONE NO : 847-234-8111
100 FIELD DRIVE SE DECISION MADE: 16-JUL-01
SUITE 240 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045
DEVICE: BODYSTAT
BODYSTAT LTD. 510(k) NO: K002835(TRADITIONAL)
ATTN: I.J. MEEUWSEN PHONE NO : 446 246 29571
PO BOX 50 SE DECISION MADE: 03-JUL-01
DOUGLAS ISLE OF MAN 510(k) STATEMENT
BRITISH ISLES, UNITED KINGDOM IM99 1DQ
DEVICE: IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 4
BOSTON SCIENTIFIC CORP. 510(k) NO: K011965(SPECIAL)
ATTN: ROBERT J MICHALIK PHONE NO : 508-650-8000
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 13-JUL-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXAC TRAC 2.0 (NOVALIS BODY MODULE)
BRAINLAB, AG 510(k) NO: K003285(TRADITIONAL)
ATTN: STEFAN VILSMELIER PHONE NO : 498 999 1568-0
AMMERTHALSTRASSE 8 SE DECISION MADE: 31-JUL-01
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL
BRANAN MEDICAL CORP. 510(k) NO: K010734(TRADITIONAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 30-JUL-01
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: BRAUN PRECISION SENSOR PRO, MODEL BP 2590
BRAUN GMBH 510(k) NO: K012035(SPECIAL)
ATTN: FRED SCHLADOR PHONE NO : 760-929-2170
6183 PASEO DEL MORTE SE DECISION MADE: 27-JUL-01
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-S
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K011728(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 09-JUL-01
BATU BELAH 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: CANDELA SPTL-1E PULSED DYE LASER
CANDELA CORP. 510(k) NO: K011092(TRADITIONAL)
ATTN: JOAN CLIFFORD PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 09-JUL-01
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US SENSOR #CG-930P; TOCO SENSOR CG-940P
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K003876(TRADITIONAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 09-JUL-01
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOZTECT SENSOR AND BIOZTECT CABLE
CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K011797(SPECIAL)
ATTN: BRAIN PARK PHONE NO : 858-535-0202
6175 NANCY RIDGE DR., #300 SE DECISION MADE: 03-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
CATCH, INC. 510(k) NO: K011689(TRADITIONAL)
ATTN: MARK E LEGAZ PHONE NO : 360-577-1062
PO BOX 2219 SE DECISION MADE: 25-JUL-01
LONGVIEW, WA 98632 510(k) STATEMENT
DEVICE: CAVEX COLORCHANGE
CAVEX HOLLAND B.V. 510(k) NO: K011419(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 312 35307763
PO BOX 852 SE DECISION MADE: 16-JUL-01
RW HAARLEM (HOLLAND), NETHERLANDS 510(k) STATEMENT
DEVICE: CAVEX STABISIL
CAVEX HOLLAND B.V. 510(k) NO: K011452(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 312 35307763
PO BOX 852 SE DECISION MADE: 19-JUL-01
RW HAARLEM (HOLLAND), NETHERLANDS 510(k) STATEMENT
DEVICE: RADS
CHASON HEALTHCARE, LLC. 510(k) NO: K011054(TRADITIONAL)
ATTN: CHARLES F NEILSON PHONE NO : 803-328-0856
715 BUCKEYE TERRACE SE DECISION MADE: 30-JUL-01
ROCK HILL SC, SC 29732 510(k) STATEMENT
DEVICE: CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
CHATTANOOGA GROUP, INC. 510(k) NO: K011243(TRADITIONAL)
ATTN: CHERYL L BAGWELL PHONE NO : 423-870-2281
4717 ADAMS ROAD SE DECISION MADE: 06-JUL-01
CHATTANOOGA, TN 37343-0489 510(k) STATEMENT
DEVICE: SMART RAD
CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K003438(TRADITIONAL)
ATTN: YESHAYAHU RAZ PHONE NO : 972 485 66233
MATAM HIGH TECHNOLOGY CENTER SE DECISION MADE: 03-JUL-01
HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10% PVP; 10% PVP IN EBSS SOLUTION
CONCEPTION TECHNOLOGIES 510(k) NO: K011481(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 02-JUL-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
CONCEPTION TECHNOLOGIES 510(k) NO: K011573(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 02-JUL-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: COPAN VIRAL TRANSYSTEM
COPAN DIAGNOSTICS, INC. 510(k) NO: K001780(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 31-JUL-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METHADONE MICROPLATE EIA URINE APPLICATION
COZART BIOSCIENCE LTD. 510(k) NO: K011131(TRADITIONAL)
ATTN: LESLY MOORE PHONE NO : 012 358 61483
45 MILTON PARK SE DECISION MADE: 31-JUL-01
ABINGDON 510(k) SUMMARY AVAILABLE FROM FDA
OXFORDSHIRE OX14 4RU, UNITED KINGDOM OX14 4RU
DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
DADE BEHRING, , INC. 510(k) NO: K011235(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
13251 NW 9TH TERRACE SE DECISION MADE: 20-JUL-01
MIAMI, FL 33182 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TGL FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K010871(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 09-JUL-01
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYCLOSPORINE CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K011112(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 17-JUL-01
GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK,, DE 19714
DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
DADE MICROSCAN, INC. 510(k) NO: K010159(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 27-JUL-01
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
DATA CRITICAL CORP. 510(k) NO: K011999(SPECIAL)
ATTN: TERESA DAVIDSON PHONE NO : 425-482-7047
19820 NORTH CREEK PKWY., #100 SE DECISION MADE: 24-JUL-01
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
DATA CRITICAL CORP. 510(k) NO: K012005(SPECIAL)
ATTN: TERESA DAVIDSON PHONE NO : 425-482-7047
19820 NORTH CREEK PKWY., #100 SE DECISION MADE: 24-JUL-01
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILE-PATIENT VIEWER
DATA CRITICAL CORPORATION 510(k) NO: K011436(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 714-546-0147
15222 DEL AMO AVE. SE DECISION MADE: 05-JUL-01
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUBYTE DENTURE BASE RESIN SYSTEM
DENTSPLY INTL. 510(k) NO: K011560(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 12-JUL-01
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES S
DENVER BIOMEDICAL, INC. 510(k) NO: K011862(SPECIAL)
ATTN: BONNIE B VIVIAN PHONE NO : 303-665-9423
14998 WEST 6TH AVE., BLDG.E700 SE DECISION MADE: 12-JUL-01
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
DEPUY ACROMED 510(k) NO: K010681(TRADITIONAL)
ATTN: FRANK MAAS PHONE NO : 508-828-3390
325 PARAMOUNT DR. SE DECISION MADE: 18-JUL-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL FX POROUS-COATED HUMERAL STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011099(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 06-JUL-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: SUMMIT DUOFIX HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011489(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 31-JUL-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS),
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K011505(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 02-JUL-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
DJ ORTHOPEDICS, LLC. 510(k) NO: K011354(TRADITIONAL)
ATTN: JAMAL D RUSHDY PHONE NO : 760-599-1674
990 PARK CENTER DRIVE, SUITE H SE DECISION MADE: 31-JUL-01
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K012024(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO :
100 INTERPACE PKWY. SE DECISION MADE: 25-JUL-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFILM WORKSTATION
EFILM MEDICAL, INC. 510(k) NO: K012211(TRADITIONAL)
ATTN: KATHY CHIN PHONE NO : 416 204 9664
500 UNIVERSITY AVE., SUITE 300 SE DECISION MADE: 31-JUL-01
TORONTO, ONTARIO, CANADA M5G 1V7 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PASS SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K012175(SPECIAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 31-JUL-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-FIX SPINAL FIXATION SYSTEM
ENDIUS, INC. 510(k) NO: K011830(TRADITIONAL)
ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 23-JUL-01
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BA
ENTIFIC MEDICAL SYSTEMS, INC. 510(k) NO: K011438(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 23-JUL-01
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THERMAL ANGEL
ESTILL MEDICAL TECHNOLOGIES, INC. 510(k) NO: K012031(SPECIAL)
ATTN: DANIEL T KISTNER PHONE NO : 214-561-1939
4144 NORTH CENTRAL EXPRESSWAY, SE DECISION MADE: 26-JUL-01
SUITE 260 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75204
DEVICE: ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
ETHICON ENDO-SURGERY, INC. 510(k) NO: K011257(TRADITIONAL)
ATTN: KATIE FORDYCE PHONE NO : 513-337-8995
4545 CREEK RD. SE DECISION MADE: 13-JUL-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPOUCH RETRIEVER
ETHICON ENDO-SURGERY, INC. 510(k) NO: K011501(TRADITIONAL)
ATTN: DOUG KENTZ PHONE NO : 513-337-8699
4545 CREEK RD. SE DECISION MADE: 19-JUL-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETYMOTIC RESEARCH ER-10D OAE PROBE
ETYMOTIC RESEARCH 510(k) NO: K011114(TRADITIONAL)
ATTN: ERIK GUNDERSEN PHONE NO : 847-228-0006
61 MARTIN LANE SE DECISION MADE: 03-JUL-01
ELK GROVE VILLAGE, IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
EXACTECH, INC. 510(k) NO: K011976(SPECIAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 16-JUL-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONA
EXACTECH, INC. 510(k) NO: K012251(SPECIAL)
ATTN: ROBERT PAXSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 31-JUL-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORALSCANNER THERMOMETER, SENSORTOUCH
EXERGEN CORP. 510(k) NO: K011291(TRADITIONAL)
ATTN: WILLIAM HARE PHONE NO : 202-783-5070
601 13TH STREET, NW SE DECISION MADE: 12-JUL-01
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FADASIS MEDICAL FM-1 NO BLENDER
FADASIS MEDICAL, INC. 510(k) NO: K011874(SPECIAL)
ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025
7601-B MURPHY DRIVE SE DECISION MADE: 20-JUL-01
MIDDLETOWN, WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERSKIN DRESSING
FIDIA ADVANCED BIOPOLYMERS SRL 510(k) NO: K001508(TRADITIONAL)
ATTN: PAOLO RAMPAZZO PHONE NO : 390 498 232416
VIA PONTE DELLA FABBRICA,3/A SE DECISION MADE: 25-JUL-01
35031 ABANO TERME (PD), ITALY 3503510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYALOMATRIX CO
FIDIA ADVANCED BIOPOLYMERS SRL 510(k) NO: K003855(TRADITIONAL)
ATTN: PAOLO RAMPAZZO PHONE NO : 39 049 8232416
VIA PONTE DELLA FABBRICA,3/A SE DECISION MADE: 03-JUL-01
35031 ABANO TERME (PD), ITALY 3503510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTE; CORE
FIRST SCIENTIFIC LIMITED 510(k) NO: K011517(TRADITIONAL)
ATTN: ADE AKINMADE PHONE NO : 44 149 5320456
7 ROSEHEYWORTH BUSINESS PARK SE DECISION MADE: 10-JUL-01
ABERTILLERY 510(k) STATEMENT
BLAENAU GWENT, WALES, UNITED KINGDOM NP13 1SP
DEVICE: RESTORE-X
FIRST SCIENTIFIC LIMITED 510(k) NO: K011520(TRADITIONAL)
ATTN: ADE AKINMADE PHONE NO : 44 149 5320456
7 ROSEHEYWORTH BUSINESS PARK SE DECISION MADE: 23-JUL-01
ABERTILLERY 510(k) STATEMENT
BLAENAU GWENT, WALES, UNITED KINGDOM NP13 1SP
DEVICE: TREMOROMETER
FLEXABLE SYSTEMS, INC. 510(k) NO: K010270(TRADITIONAL)
ATTN: ROBERT M TRIPP PHONE NO : 480-837-4868
16410 E. TOMSTONE AVENUE SE DECISION MADE: 25-JUL-01
FOUNTAIN HILLS, AZ 85268-6545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRUGFREE@HOME THC/COC TEST, MODEL 200T
FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K002253(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 949-595-0673
23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 03-JUL-01
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRA
FRESENIUS HEMOTECHNOLOGY, INC. 510(k) NO: K012178(SPECIAL)
ATTN: TOM TROTTER PHONE NO : 425-497-1197
6675 185TH AVE. NE, SUITE 100 SE DECISION MADE: 23-JUL-01
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCORD 72
GATEWAY ALLOYS, INC. 510(k) NO: K011626(ABBREVIATED)
ATTN: JOHN C CONSTANTINE PHONE NO : 888-357-7291
1702 SCHERER PKWY. SE DECISION MADE: 16-JUL-01
ST. CHARLES, MO 63303 510(k) STATEMENT
DEVICE: CONCORD 82
GATEWAY ALLOYS, INC. 510(k) NO: K011628(ABBREVIATED)
ATTN: JOHN C CONSTANTINE PHONE NO : 888-357-7291
1702 SCHERER PKWY. SE DECISION MADE: 16-JUL-01
ST. CHARLES, MO 63303 510(k) STATEMENT
DEVICE: HYSTEROSCOPES
GLOBAL ENDOSCOPY, INC. 510(k) NO: K003802(TRADITIONAL)
ATTN: NICK MIRCEA PHONE NO : 847-301-2733
914 W. ESTES CT. SE DECISION MADE: 22-JUL-01
SCHAUMBURG, IL 60193-4426 510(k) STATEMENT
DEVICE: GYNECOLOGICAL LAPAROSCOPES
GLOBAL ENDOSCOPY, INC. 510(k) NO: K003805(TRADITIONAL)
ATTN: NICK MIRCEA PHONE NO : 847-301-2733
914 W. ESTES CT. SE DECISION MADE: 22-JUL-01
SCHAUMBURG, IL 60193-4426 510(k) STATEMENT
DEVICE: ARTHROSCOPES
GLOBAL ENDOSCOPY, INC. 510(k) NO: K003831(TRADITIONAL)
ATTN: NICK MIRCEA PHONE NO : 888-434-3398
914 W. ESTES CT. SE DECISION MADE: 20-JUL-01
SCHAUMBURG, IL 60193-4426 510(k) STATEMENT
DEVICE: VACUETTE SAFETY BLOOD COLLECTION SET
GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K011786(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 12-JUL-01
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
GUIDANT CORP. 510(k) NO: K011881(SPECIAL)
ATTN: SABA MODJARRAD PHONE NO : 408-845-1067
26531 YNEZ RD. SE DECISION MADE: 18-JUL-01
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIKING OPTIMA GUIDING CATHETER
GUIDANT CORP. 510(k) NO: K012002(SPECIAL)
ATTN: STACEY SIMON PHONE NO : 909-914-4527
26531 YNEZ RD. SE DECISION MADE: 26-JUL-01
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BW ACUPUNCTURE NEEDLES
H F INTL. CO. 510(k) NO: K011669(TRADITIONAL)
ATTN: JOHN N POLITIS PHONE NO : 213-534-8888
865 SOUTH FIGUEROA STREET SE DECISION MADE: 09-JUL-01
SUITE 2308 510(k) STATEMENT
LOS ANGELES, CA 90017
DEVICE: SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, S
HARVEST TECHNOLOGIES, CORP. 510(k) NO: K011032(TRADITIONAL)
ATTN: ANNETTE FAGNANT PHONE NO : 508-732-7530
40 GRISSOM ROAD SE DECISION MADE: 03-JUL-01
PLYMOUTH, MA 02360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HA-TI (HAND TITANIUM SCREW) IMPLANT
HATI DENTAL AG. 510(k) NO: K003045(TRADITIONAL)
ATTN: HEINZ E WICK PHONE NO : 610-521-4073
252 W. RIDLEY AVENUE SE DECISION MADE: 12-JUL-01
RIDLEY PARK, PA 19078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVISION CHEM
HERAEUS KULZER, INC. 510(k) NO: K010541(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 S. LAFAYETTE BLVD. SE DECISION MADE: 31-JUL-01
SOUTH BEND, IN 46614 510(k) STATEMENT
DEVICE: PREMIUM
HERAEUS KULZER, INC. 510(k) NO: K011130(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785
99 BUSINESS PARK DRIVE SE DECISION MADE: 05-JUL-01
ARMONK, NY 10504-1720 510(k) STATEMENT
DEVICE: MODIFICATION TO XIA SPINE SYSTEM
HOWMEDICA OSTEONICS 510(k) NO: K012027(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 20-JUL-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMAN II HYBRID RING CLAMP
HOWMEDICA OSTEONICS CORP. 510(k) NO: K011948(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 13-JUL-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT ALL POLY CUP
HOWMEDICA OSTEONICS CORP. 510(k) NO: K012026(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-934-4354
59 ROUTE 17 SE DECISION MADE: 18-JUL-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
HU-FRIEDY MFG. CO.,INC. 510(k) NO: K012060(SPECIAL)
ATTN: KEITH DUNN PHONE NO : 773-975-6100
3232 NORTH ROCKWELL ST. SE DECISION MADE: 27-JUL-01
CHICAGO, IL 60618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT SYSTEM
I-STAT CORP. 510(k) NO: K011478(TRADITIONAL)
ATTN: PAUL VANDERWERF PHONE NO : 609-469-0242
104 WINDSOR CENTER DR. SE DECISION MADE: 02-JUL-01
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
IBT, INC. 510(k) NO: K011155(ABBREVIATED)
ATTN: RUTH FEICHT PHONE NO : 770-582-0662
6000 LIVE OAK PARKWAY, SE DECISION MADE: 12-JUL-01
SUITE 107 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30093
DEVICE: TELEPAX
IMED SYSTEMS & CONSULTING, LLC. 510(k) NO: K011173(ABBREVIATED)
ATTN: KENNETH P BONNER PHONE NO : 410-346-7869
4715 TRAIL COURT SE DECISION MADE: 11-JUL-01
WESTMINSTER, MD 21158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STA
IMPLEX CORP. 510(k) NO: K011904(SPECIAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 19-JUL-01
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMME
IMPLEX CORP. 510(k) NO: K012095(SPECIAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 26-JUL-01
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRO2, HS-75
INNOVISION, INC. 510(k) NO: K011914(TRADITIONAL)
ATTN: DON M WOODFORD PHONE NO : 402-558-3000
3125 SOUTH 61ST AVE. SE DECISION MADE: 27-JUL-01
OMAHA, NE 68106-3675 510(k) STATEMENT
DEVICE: QUANTA PLEX ENA PROFILE 4
INOVA DIAGNOSTICS, INC. 510(k) NO: K011140(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 27-JUL-01
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K011566(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 09-JUL-01
SAN DIEGO, CA 92131-1234 510(k) STATEMENT
DEVICE: QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K011570(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 09-JUL-01
SAN DIEGO, CA 92131-1234 510(k) STATEMENT
DEVICE: PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K010599(SPECIAL)
ATTN: JOHN CLAY PHONE NO : 732-548-5700
6 OLSEN AVE. SE DECISION MADE: 02-JUL-01
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2
INTERPORE CROSS INTL. 510(k) NO: K004003(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 19-JUL-01
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
INTERSECT SYSTEMS, INC. 510(k) NO: K011692(TRADITIONAL)
ATTN: MARK LEGAZ PHONE NO : 360-577-1062
P.O. BOX 2219 SE DECISION MADE: 25-JUL-01
LONGVIEW, WA 98632 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL ULTRASONIC SHEARS
INTUITIVE SURGICAL, INC. 510(k) NO: K011281(TRADITIONAL)
ATTN: MICHAEL YRAMATEGUI PHONE NO : 650-237-7000
1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 24-JUL-01
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTON THERAPY SYSTEM
ION BEAM APPLICATIONS S.A. 510(k) NO: K983024(TRADITIONAL)
ATTN: JOHN B REISS PHONE NO : 215-972-7124
CENTRE SQUARE WEST, 38TH FLOOR SE DECISION MADE: 12-JUL-01
PHILADELPHIA, PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIL FOR EMBRYO CULTURE
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K011938(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 18-JUL-01
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
ISOAID 510(k) NO: K011205(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 10-JUL-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN TEN-S
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K011492(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 05-JUL-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JAS CALCIUM (ARSENAZO) REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K011441(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 09-JUL-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: UREA NITROGEN (BUN) LIQUID REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K011596(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 17-JUL-01
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALKALINE PHOSPHATASE LIQUID REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K011599(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 20-JUL-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: GLUCOSE (HEXOKINASE)
JAS DIAGNOSTIC, INC. 510(k) NO: K011900(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 31-JUL-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
JB STAR SDN BHD 510(k) NO: K010546(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 10-JUL-01
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
JOSTRA AG 510(k) NO: K003551(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 302-454-9959
17511 ARMSTRONG AVE. SE DECISION MADE: 11-JUL-01
IRVINE, CA 92614-5686 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY C1-INA
KAMIYA BIOMEDICAL CO. 510(k) NO: K011780(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 25-JUL-01
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
KHRUNICHEV STATE RESEARCH & PRODUC510(k) NO: K011312(ABBREVIATED)
ATTN: W T WORKMAN PHONE NO : 210-490-6999
1811 COPPER RIDGE DRIVE SE DECISION MADE: 18-JUL-01
SAN ANTONIO, TX 78259-3612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
KIMBERLY-CLARK CORP. 510(k) NO: K011713(TRADITIONAL)
ATTN: MARCIA JOHNSON PHONE NO : 770-587-8324
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 05-JUL-01
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
KLS-MARTIN L.P. 510(k) NO: K990667(TRADITIONAL)
ATTN: ARTHUR J WARD PHONE NO : 727-376-4154
3234 ELLA LANE SE DECISION MADE: 27-JUL-01
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STREERABLE PTCA GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K011968(SPECIAL)
ATTN: JEFF PUMPER PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 25-JUL-01
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASER PERIPHERALS REUSABLE HOLMIUM FIBER
LASER PERIPHERALS, LLC. 510(k) NO: K011207(TRADITIONAL)
ATTN: NANCY ARNOLD PHONE NO : 763-525-8460
1000 BOONE AVE NORTH SE DECISION MADE: 24-JUL-01
SUITE 300 510(k) STATEMENT
GOLDEN VALLEY, MN 55427
DEVICE: MODIFIED M-IV MAMMOGRAPHY SYSTEM
LORAD, A HOLOGIC CO. 510(k) NO: K011987(SPECIAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203-790-1188
36 APPLE RIDGE RD. SE DECISION MADE: 11-JUL-01
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPREMA POWERED WHEELCHAIR
LUIGI CHINETTI 510(k) NO: K010600(TRADITIONAL)
ATTN: LUIGI CHINETTI PHONE NO : 860-434-7165
P.O. BOX 292 SE DECISION MADE: 13-JUL-01
EAST HADDAM, CT 06423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPOREPX PEDIATRIC SYSTEM
MACROPORE, INC. 510(k) NO: K002207(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 11-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE OS SPINAL SYSTEM
MACROPORE, INC. 510(k) NO: K010911(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 20-JUL-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINION ENHANCEMENT PACKAGE
MARCONI MEDICAL SYSTEMS 510(k) NO: K011296(TRADITIONAL)
ATTN: DUANE PRASCHAN PHONE NO : 440-483-5743
595 MINER RD. SE DECISION MADE: 19-JUL-01
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES
MASIMO CORP. 510(k) NO: K011851(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 11-JUL-01
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORTHEAST PROTON THERAPY CENTER
MASSACHUSETTS GENERAL HOSPITAL 510(k) NO: K983332(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST. N.W. SE DECISION MADE: 20-JUL-01
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDEWIRE INTRODUCER SAFETY NEEDLE
MEDAMICUS, INC. 510(k) NO: K011085(TRADITIONAL)
ATTN: DENNIS S MADISON PHONE NO : 763-577-2233
15301 HIGHWAY 55 WEST SE DECISION MADE: 09-JUL-01
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES
MEDDEV CORP. 510(k) NO: K011740(SPECIAL)
ATTN: SUZANNA BRICK PHONE NO : 408-730-9702
730 NORTH PASTORIA AVE. SE DECISION MADE: 02-JUL-01
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K011731(TRADITIONAL)
ATTN: DARWIN RICHARDSON PHONE NO : 805-987-7891
5300 ADOLFO ROAD SE DECISION MADE: 05-JUL-01
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MEDICAL DEPOT POWER NEB 1
MEDICAL DEPOT, INC. 510(k) NO: K012006(SPECIAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 13-JUL-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIFIX URETEROSCOPE
MEDIFIX, INC. 510(k) NO: K011325(TRADITIONAL)
ATTN: GEORGE ALBULESCU PHONE NO : 847-965-1898
8727 NARRAGANSETT SE DECISION MADE: 25-JUL-01
MORTON GROVE, IL 60053-0000 510(k) STATEMENT
DEVICE: QCU ANALYTICAL SOFTWARE PACKAGE
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K011582(TRADITIONAL)
ATTN: J.J. HOLLANDER PHONE NO : 31 71 5223244
POORTGEBOUW RIJNSBURGERWEG 10 SE DECISION MADE: 31-JUL-01
LEIDEN, NETHERLANDS 2333 AA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE GROUNDING PAD
MEDLINE INDUSTRIES, INC. 510(k) NO: K011515(TRADITIONAL)
ATTN: STACEY L BOLEN PHONE NO : 847-837-2843
ONE MEDLINE PL. SE DECISION MADE: 13-JUL-01
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
MEDTRONIC SOFAMOR DANEK 510(k) NO: K011998(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-344-0807
1800 PYRAMID PLACE SE DECISION MADE: 26-JUL-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
MEDTRONIC, INC. 510(k) NO: K011395(SPECIAL)
ATTN: CHARLES DOWD PHONE NO : 763-514-2875
8299 CENTRAL AVE., N.E. SE DECISION MADE: 12-JUL-01
MAIL STOP: P108 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55432
DEVICE: TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41
MEDTRONIC, INC. 510(k) NO: K011864(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 763-391-9183
7611 NORTHLAND DRIVE SE DECISION MADE: 09-JUL-01
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAR THERMOMETER, MODELS ST613C AND ST613F
MESURE TECHNOLOGY 510(k) NO: K011254(TRADITIONAL)
ATTN: PHIL ZULUETA PHONE NO : 818-354-1566
P.O. BOX 2249 SE DECISION MADE: 10-JUL-01
MISSION VIEJO, CA 92690 510(k) STATEMENT
DEVICE: MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K011955(SPECIAL)
ATTN: ROB HOPKINS PHONE NO : 613 977 51234
57 ASTER AVE. SE DECISION MADE: 16-JUL-01
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: WUNDCATH CONDUCTION CATHETER
MICOR, INC. 510(k) NO: K003966(TRADITIONAL)
ATTN: JEREMIAH COSTELLO PHONE NO : 412-487-1113
2855 OXFORD BLVD. SE DECISION MADE: 17-JUL-01
ALLISON PARK, PA 15101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDIN
MICRONET MEDICAL, INC. 510(k) NO: K010008(TRADITIONAL)
ATTN: CHARLES LEHMAN PHONE NO : 651-773-3181
1839 BUERKLE RD. SE DECISION MADE: 16-JUL-01
WHITE BEAR LAKE, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
MISONIX, INC. 510(k) NO: K012028(SPECIAL)
ATTN: ALBERT F CLANCY PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 27-JUL-01
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
MISSION MEDICL DEVICES 510(k) NO: K003254(TRADITIONAL)
ATTN: DONALD V CANAL PHONE NO : 760-443-7705
3525 DEL MAR HEIGHTS ROAD #430 SE DECISION MADE: 09-JUL-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MO
MOGUL ENTERPRISES 510(k) NO: K011734(SPECIAL)
ATTN: JAMIL MOGUL PHONE NO : 408-629-3340
6387 SAN IGNACIO AVENUE SE DECISION MADE: 03-JUL-01
SAN JOSE, CA 95119 510(k) STATEMENT
DEVICE: MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (
MPS ACACIA 510(k) NO: K011117(TRADITIONAL)
ATTN: FERGIE F FERGUSON PHONE NO : 714-257-0470
499 NIBUS ST., SUITE E SE DECISION MADE: 09-JUL-01
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTP LAPAROMAT DISPOSABLE TUBING SET
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K011360(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 19-JUL-01
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON
MULTISAFE SDN BHD 510(k) NO: K011293(TRADITIONAL)
ATTN: ABD HADI BIN HUSIN PHONE NO : 605 291 1055
LOT 764 SE DECISION MADE: 10-JUL-01
BIDOR INDUSTRIAL ESTATE 510(k) STATEMENT
35500 BIDOR, PERAK, MALAYSIA 35500
DEVICE: GSI AUDERA
NICOLET VASCULAR, INC. 510(k) NO: K011135(TRADITIONAL)
ATTN: DAVID W WAGNER PHONE NO : 303-431-9400
6355 JOYCE DR. SE DECISION MADE: 26-JUL-01
GOLDEN, CO 80403 510(k) STATEMENT
DEVICE: PURESPERM BUFFER
NIDACON INTERNATIONAL AB 510(k) NO: K011606(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 12-JUL-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM000
NIEN MADE ELECTRNICS CORP. 510(k) NO: K011310(ABBREVIATED)
ATTN: JAMES M DELANEY PHONE NO : 978-371-0066
100 MAIN STREET SE DECISION MADE: 20-JUL-01
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K012194(TRADITIONAL)
ATTN: PHONE NO :
2508-13 NAKAGO SE DECISION MADE: 20-JUL-01
KOMOCHI-MURA, KITAGUNMA-GUN 510(k) SUMMARY AVAILABLE FROM FDA
GUNMA-KEN, JAPAN 377-0293 THIRD PARTY REVIEW
DEVICE: PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
NUMED, INC. 510(k) NO: K011557(SPECIAL)
ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 12-JUL-01
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
OHMEDA MEDICAL 510(k) NO: K011549(TRADITIONAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-888-5204
8880 GORMAN RD. SE DECISION MADE: 19-JUL-01
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY CONTROL MICRO INSERTER, MODEL ON385
OPHTEC USA, INC. 510(k) NO: K011498(TRADITIONAL)
ATTN: RICK MCCARLEY PHONE NO : 561-989-8767
6421 CONGRESS AVE., SUITE 112 SE DECISION MADE: 09-JUL-01
BOCA RATON, FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R STENT BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K010107(TRADITIONAL)
ATTN: ROBERT FRECHETTE PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 31-JUL-01
FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBAC
ORIDION MEDICAL 1987 LTD. 510(k) NO: K011668(TRADITIONAL)
ATTN: SANDY BROWN PHONE NO : 972 258 99115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 09-JUL-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
ORIENTAL SYSTEM TECHNOLOGY, INC. 510(k) NO: K010235(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 09-JUL-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: STARBAND CRANIAL ORTHOSIS
ORTHOMERICA PRODUCTS, INC. 510(k) NO: K011350(TRADITIONAL)
ATTN: WILLIAM H VON OEHSEN PHONE NO : 202-347-0066
1001 PENNSYLVANIA AVENUE SE DECISION MADE: 03-JUL-01
6TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: SCS DT-02 TRANSVERSE CONNECTOR
ORTHOTEC, L.L.C. 510(k) NO: K003823(SPECIAL)
ATTN: PATRICK BERTRANOU PHONE NO : 310-557-2000
546 HILLGREEN DR. SE DECISION MADE: 11-JUL-01
BEVERLY HILLS, CA 90212-4110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO-DRIVE LAG SCREW SYSTEM
OSTEOMED CORP. 510(k) NO: K010964(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 05-JUL-01
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
OSTEOMEDICS 510(k) NO: K011118(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 20-JUL-01
PARAMUS, NJ 07672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
OSTEX INTL., INC. 510(k) NO: K011052(TRADITIONAL)
ATTN: NANCY JS MALLINAK PHONE NO : 206-292-8082
2203 AIRPORT WAY SOUTH, SE DECISION MADE: 30-JUL-01
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
SEATTLE, WA 98134
DEVICE: MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 129
PAJUNK GMBH 510(k) NO: K011997(TRADITIONAL)
ATTN: MARTIN HAUGER PHONE NO : 497 704 92910
AM HOLZPLATZ 5-7 SE DECISION MADE: 10-JUL-01
GEISINGEN, GERMANY D-78187 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
PAN PROBE BIOTECH, INC. 510(k) NO: K012107(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 20-JUL-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIVESURE BENZODIAZEPINES SCREEN TESTS
PAN PROBE BIOTECH, INC. 510(k) NO: K012131(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 20-JUL-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIVESURE BARBITURATES SCREEN TEST
PAN PROBE BIOTECH, INC. 510(k) NO: K012133(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 20-JUL-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
PARALLAX MEDICAL, INC. 510(k) NO: K011206(ABBREVIATED)
ATTN: RICHARD M RUEDY PHONE NO : 831-439-0130
940 DISC DR. SE DECISION MADE: 18-JUL-01
SCOTTS VALLEY, CA 95066-4544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROLOGIC
PCK ELECTRONIC INDUSTRY AND TRADE 510(k) NO: K011311(TRADITIONAL)
ATTN: CENGIZ KABAKCI PHONE NO : 903 124 916010
59/1 SANCAK, CANKAYA SE DECISION MADE: 10-JUL-01
ANKARA, TURKEY 06550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AV 800 VENTILATOR
PENLON LTD. 510(k) NO: K010317(TRADITIONAL)
ATTN: ANTHONY PARSONS PHONE NO : 440 123 5547000
RADLEY ROAD SE DECISION MADE: 23-JUL-01
ABINGDON 510(k) SUMMARY AVAILABLE FROM FDA
OXFORDSHIRE, UNITED KINGDOM OX14 3PH
DEVICE: PRIMA OXYGEN MONITOR
PENLON LTD. 510(k) NO: K010318(TRADITIONAL)
ATTN: ANTHONY PARSONS PHONE NO : 044 123 5547000
RADLEY ROAD SE DECISION MADE: 23-JUL-01
ABINGDON 510(k) SUMMARY AVAILABLE FROM FDA
OXFORDSHIRE, UNITED KINGDOM OX14 3PH
DEVICE: CASCADE BATH, MODEL 6900
PENNER MANUFACTURING, INC. 510(k) NO: K012057(TRADITIONAL)
ATTN: VICKIE J BRADY PHONE NO : 402-636-8230
1500 WOODMEN TOWER SE DECISION MADE: 19-JUL-01
OHAHA, NE 68102 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: SUPERIOR BATH, MODEL 6300
PENNER MANUFACTURING, INC. 510(k) NO: K012061(TRADITIONAL)
ATTN: VICKIE BRADY PHONE NO : 402-636-8230
1500 WOODMEN TOWER SE DECISION MADE: 19-JUL-01
OHAHA, NE 68102 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: PLUS CANCELLOUS BONE SCREWS
PLUS ORTHOPEDICS 510(k) NO: K011719(SPECIAL)
ATTN: HARTMUT LOCH, RAC PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 02-JUL-01
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM BLAST
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K011993(SPECIAL)
ATTN: GENE R KULON PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 13-JUL-01
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
PRIMARY CARE SOLUTIONS, INC. 510(k) NO: K000265(TRADITIONAL)
ATTN: NORMAN RUEDT PHONE NO : 973-728-1278
339 STONETOWN ROAD SE DECISION MADE: 12-JUL-01
RINGWOOD, NJ 07456 510(k) STATEMENT
DEVICE: PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR D
PRIMARY CARE SOLUTIONS, INC. 510(k) NO: K000266(TRADITIONAL)
ATTN: NORMAN RUEDT PHONE NO : 973-728-1278
339 STONETOWN ROAD SE DECISION MADE: 12-JUL-01
RINGWOOD, NJ 07456 510(k) STATEMENT
DEVICE: MITYVAC
PRISM ENTERPRISES, INC. 510(k) NO: K011532(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET N.W. SE DECISION MADE: 30-JUL-01
WASHINGTON, DC 20004-5600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & S
PROCTER & GAMBLE CO. 510(k) NO: K011171(TRADITIONAL)
ATTN: MARK M ANDERSON PHONE NO : 513-634-5196
6110 CENTER HILL AVE. SE DECISION MADE: 02-JUL-01
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUUM ASSISTED CORE BIOPSY DEVICE
PROMEX, INC. 510(k) NO: K010400(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-736-0128
3049 HUDSON STREET SE DECISION MADE: 24-JUL-01
P.O. BOX 787 510(k) STATEMENT
FRANKLIN, IN 46131
DEVICE: LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K011712(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 626-913-1798
889 SOUTH AZUSA AVENUE SE DECISION MADE: 17-JUL-01
CITY OF INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED O
PWA INDUSTRIES SDN. BHD. 510(k) NO: K011895(TRADITIONAL)
ATTN: K. KARUNAKARAN PHONE NO : 011 609 5670835
LOT 93, SEMAMBU INDUST. ESTATE SE DECISION MADE: 09-JUL-01
KUANTAN, PAHANG, MALAYSIA 25350 510(k) STATEMENT
DEVICE: POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CON
QUALITY LATEX PRODUCTS MALAYSIA SD510(k) NO: K011995(TRADITIONAL)
ATTN: SHARENE WAN PHONE NO : 605 527 7228
18-20, JALAN KILANG 2 SE DECISION MADE: 31-JUL-01
JELAPANG LIGHT INDUST. ESTATE 510(k) STATEMENT
IPOH. PERAK, MALAYSIA 30100
DEVICE: LIPOPRINT SYSTEM, LDL SUBFRACTIONS
QUANTIMETRIX CORP. 510(k) NO: K010337(TRADITIONAL)
ATTN: GEBHARD NEYER PHONE NO : 310-536-0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 25-JUL-01
REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAMBLER
RAMBLER MOBILITY, INC. 510(k) NO: K011401(TRADITIONAL)
ATTN: JOEL HUSTED PHONE NO : 804-525-1544
1401 OLD ELKTON DRIVE SE DECISION MADE: 13-JUL-01
FOREST, VA 24551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX DIGOXIN
RANDOX LABORATORIES, LTD. 510(k) NO: K011302(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413
55 DIAMOND RD. SE DECISION MADE: 02-JUL-01
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT
DEVICE: RANDOX PHENOBARBITAL
RANDOX LABORATORIES, LTD. 510(k) NO: K011303(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 442413
55 DIAMOND RD. SE DECISION MADE: 02-JUL-01
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT
DEVICE: PRAIRIE CRUISER
RAYE'S, INC. 510(k) NO: K002580(TRADITIONAL)
ATTN: WILLARD L FRICKEY PHONE NO : 800-537-6454
204 WEST 2ND ST. SE DECISION MADE: 03-JUL-01
P.O. BOX 320 510(k) STATEMENT
ELLIS, KS 67637
DEVICE: CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
REYNOLDS MEDICAL LTD. 510(k) NO: K011345(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 RT. 17 S. SE DECISION MADE: 20-JUL-01
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFECARD CF 7 DAY
REYNOLDS MEDICAL LTD. 510(k) NO: K011837(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1708
377 RT. 17 S. SE DECISION MADE: 13-JUL-01
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOOTH SHADE RESIN MATERIAL
RITE-DENT MANUFACTURING CORP. 510(k) NO: K011453(TRADITIONAL)
ATTN: CESAR E VELIZ PHONE NO : 305-693-8626
1056 EAST 33RD ST. SE DECISION MADE: 23-JUL-01
HIALEAH, FL 33013-3526 510(k) STATEMENT
DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
ROCHDIAG 510(k) NO: K011658(ABBREVIATED)
ATTN: HELEN T TORNEY PHONE NO : 317-576-7643
9115 HAGUE ROAD SE DECISION MADE: 31-JUL-01
PO BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOO
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K011352(ABBREVIATED)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 20-JUL-01
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSU
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K011539(ABBREVIATED)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 20-JUL-01
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: SUREVUE URINE HCG
SA SCIENTIFIC, INC. 510(k) NO: K010522(TRADITIONAL)
ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 31-JUL-01
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K011456(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 N. WABASH AVENUE SE DECISION MADE: 17-JUL-01
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601
DEVICE: POWDERED LATEX EXAMINATION GLOVES
SELTOM PACIFIC SDN. BHD. 510(k) NO: K011922(TRADITIONAL)
ATTN: S. SEGARAN PHONE NO : 603 563 664631
LOT 25, JALAN PJS 7/17 SE DECISION MADE: 05-JUL-01
SUNWAY INDUSTRIAL PARK 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150
DEVICE: POWDERED BLUE NITRILE EXAMINATION GLOVES
SELTOM PACIFIC SDN. BHD. 510(k) NO: K011924(TRADITIONAL)
ATTN: S SEGARAN PHONE NO : 603 563 64631
LOT 25, JALAN PJS 7/17 SE DECISION MADE: 10-JUL-01
SUNWAY INDUSTRIAL PARK 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150
DEVICE: BIOPSY SITE MARKER
SENORX, INC. 510(k) NO: K011402(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 16-JUL-01
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
SENSORMEDICS CORP. 510(k) NO: K012034(SPECIAL)
ATTN: ALEX STENZLER PHONE NO : 800-520-4368
22705 SAVI RANCH PKWY. SE DECISION MADE: 24-JUL-01
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG EVERSHARP PLASTIC PRO510(k) NO: K011882(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 10-JUL-01
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG EVERSHARP PLASTIC PRO510(k) NO: K011883(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 17-JUL-01
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG EVERSHARP PLASTIC PRO510(k) NO: K011884(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 17-JUL-01
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG EVERSHARP PLASTIC PRO510(k) NO: K011885(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 16-JUL-01
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
SHIMADZU CORP. 510(k) NO: K011141(TRADITIONAL)
ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVENUE SE DECISION MADE: 03-JUL-01
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K012016(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVENUE SE DECISION MADE: 20-JUL-01
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
SIGHTLINE TECHNOLOGIES LTD. 510(k) NO: K011825(SPECIAL)
ATTN: SIMCHA EDELL PHONE NO : 972 485 50447
ADVANCED TECHNOLOGY CENTER SE DECISION MADE: 11-JUL-01
MATAM, HAIFA, ISRAEL 31905 510(k) STATEMENT
DEVICE: SIGN IM NAIL
SIGN, INC. 510(k) NO: K011129(TRADITIONAL)
ATTN: JEANNE DILLNER PHONE NO : 509-371-1107
2950 GEORGE WASHINGTON WAY SE DECISION MADE: 11-JUL-01
RICHLAND, WA 99352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPO
SIMS PORTEX, INC. 510(k) NO: K011925(TRADITIONAL)
ATTN: BRAIN D FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 12-JUL-01
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORIC LITE LENS
SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K011256(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 17-JUL-01
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: ISODAN
SPECIALITES SEPTODONT 510(k) NO: K010415(TRADITIONAL)
ATTN: PETER S REICHERZ PHONE NO : 202-857-6378
1050 CONNECTICUT AVE. NW SE DECISION MADE: 23-JUL-01
WASHINGTON, DC 20036-5339 510(k) STATEMENT
DEVICE: SPINE WORKS COLLAR
SPINE WORKS 510(k) NO: K003662(TRADITIONAL)
ATTN: DAN FARLEY PHONE NO : 231-922-0177
10170 E. CHERRY BEND RD. SE DECISION MADE: 09-JUL-01
TRAVERSE CITY, MI 49684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F
ST.JUDE MEDICAL 510(k) NO: K011766(SPECIAL)
ATTN: ANGELA BYLAND PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 03-JUL-01
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
STRYKER ENDOSCOPY 510(k) NO: K011319(TRADITIONAL)
ATTN: RYAN YEARSLEY PHONE NO : 408-567-9100
2590 WALSH AVE. SE DECISION MADE: 20-JUL-01
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE AMPHETAMINE DIPSTRIP ASSAY
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K011499(TRADITIONAL)
ATTN: MING SUN PHONE NO : 856-401-1080
604 VPR CENTER SE DECISION MADE: 17-JUL-01
1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012
DEVICE: RF-IVD WIRELESS DOSIMETER-MODEL 1133
SUN NUCLEAR CORP. 510(k) NO: K011332(TRADITIONAL)
ATTN: WILLIAM E SIMON PHONE NO : 321-259-6862
425-A PINEDA COURT SE DECISION MADE: 26-JUL-01
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS 9000 SERIES CPAP, MODEL 9001
SUNRISE MEDICAL HHG, INC. 510(k) NO: K011229(SPECIAL)
ATTN: JIM FROEHLICH PHONE NO : 814-443-7692
100 DEVILBISS DR. SE DECISION MADE: 11-JUL-01
SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
SYNTHES (USA) 510(k) NO: K011170(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 05-JUL-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES CURVED RECONSTRUCTION PLATE
SYNTHES (USA) 510(k) NO: K011334(TRADITIONAL)
ATTN: MATTHEW M HALL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 27-JUL-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHS ONE-THIRD TUBULAR DCL PLATE
SYNTHES (USA) 510(k) NO: K011335(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 27-JUL-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES (USA) 510(k) NO: K011969(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 19-JUL-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
SYVA CO. 510(k) NO: K011947(SPECIAL)
ATTN: SUSAN L COLLINS PHONE NO : 408-366-3840
20400 MARIANI AVE. SE DECISION MADE: 02-JUL-01
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
SYVA CO., DADE BEHRING, INC. 510(k) NO: K011920(SPECIAL)
ATTN: SUSAN L COLLINS PHONE NO : 408-366-3840
20400 MARIANI AVE. SE DECISION MADE: 02-JUL-01
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 100 ACTIVITY MONITOR
TELECOM MEDICAL, INC. 510(k) NO: K011429(TRADITIONAL)
ATTN: THOMAS C WEHMAN PHONE NO : 408-739-7887
10900 LUCKY OAK COURT SE DECISION MADE: 13-JUL-01
CUPERTINO, CA 95014 510(k) STATEMENT
DEVICE: TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND
TERATECH CORP. 510(k) NO: K012191(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006
19030 PORTOS DRIVE SE DECISION MADE: 26-JUL-01
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K011804(SPECIAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 09-JUL-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLAVORED MALE LATEX CONDOM
THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K011253(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK RD. SE DECISION MADE: 20-JUL-01
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
THE BINDING SITE, LTD. 510(k) NO: K011662(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 30-JUL-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
THE BINDING SITE, LTD. 510(k) NO: K011663(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 30-JUL-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY E
THE OLYMPUS OPTICAL CO. 510(k) NO: K011869(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 25-JUL-01
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPLITTABLE SHEATH INTRODUCER KIT
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K004025(TRADITIONAL)
ATTN: KIMBERLY A FISCHER PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 19-JUL-01
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAIDED GUIDING INTRODUCER
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K004026(TRADITIONAL)
ATTN: PETER J RAPP PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY. SE DECISION MADE: 09-JUL-01
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODE
TIARA MEDICAL SYSTEMS, INC. 510(k) NO: K012207(SPECIAL)
ATTN: GEOFFREY SLEEPER PHONE NO : 216-521-1220
14414 DETROIT AVE, SUITE 205 SE DECISION MADE: 23-JUL-01
LAKEWOOD, OH 44107 510(k) STATEMENT
DEVICE: CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
TILLOTSON HEALTHCARE CORP. 510(k) NO: K011497(TRADITIONAL)
ATTN: THOMAS N TILLOTSON PHONE NO : 800-445-6830
360 ROUTE 101 SE DECISION MADE: 10-JUL-01
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
TITAN IMPLANTS 510(k) NO: K003818(TRADITIONAL)
ATTN: LYNETTE L HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 05-JUL-01
FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISTITE II DC
TOKUYAMA AMERICA, INC. 510(k) NO: K011685(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040
2000 M STREET, NW SE DECISION MADE: 31-JUL-01
SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
TORNIER S.A. 510(k) NO: K011942(SPECIAL)
ATTN: IRENE GOSSET PHONE NO : 330 476 613500
RUE DOYEN GOSSE SE DECISION MADE: 13-JUL-01
ST. ISMIER, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
TOTOKU ELECTRIC CO., LTD 510(k) NO: K012099(TRADITIONAL)
ATTN: KAY HAMAGUCHI PHONE NO : 011 815 96370190
319 AKENO SE DECISION MADE: 31-JUL-01
OBATA-CHO, WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA
MIEKEN, JAPAN 519-05
DEVICE: VORTEX
ULTRAVISUAL MEDICAL SYSTEMS 510(k) NO: K012097(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 12-JUL-01
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
UNISENSOR AG 510(k) NO: K003580(ABBREVIATED)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVENUE SE DECISION MADE: 31-JUL-01
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL DYNAMICS MESH CAGE SYSTEM
UNITED STATES SURGICAL, A DIVISION510(k) NO: K003709(TRADITIONAL)
ATTN: JENNIFER E SCHUCK PHONE NO : 203-845-4512
150 GLOVER AVE. SE DECISION MADE: 18-JUL-01
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARISEED 7.0
VARIAN MEDICAL SYSTEMS 510(k) NO: K012017(SPECIAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3100 HANSEN WAY M/S F055 SE DECISION MADE: 12-JUL-01
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVENT 201 PORTABLE VENTILATOR
VERSAMED LTD. 510(k) NO: K011957(SPECIAL)
ATTN: KEN RAICHMAN PHONE NO : 972 364 96822
ATIDIM INDUSTRIAL PARK, BLDG 2 SE DECISION MADE: 18-JUL-01
P.O. BOX 58135 510(k) SUMMARY AVAILABLE FROM FDA
TEL-AVIV, ISRAEL 61580
DEVICE: PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORI
VIDAMED, INC. 510(k) NO: K011787(SPECIAL)
ATTN: YI CHEN PHONE NO : 510-492-4934
46107 LANDING PKWY. SE DECISION MADE: 06-JUL-01
FREMONT, CA 94538 510(k) STATEMENT
DEVICE: MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/S
VISICU, INC. 510(k) NO: K012171(SPECIAL)
ATTN: MICHAEL BRESLOW PHONE NO : 410-276-1960
2400 BOSTON STREET SE DECISION MADE: 24-JUL-01
BALTIMORE, MD 21224 510(k) STATEMENT
DEVICE: VIVO 200 DPS VIVOSCAN
VIVOSONIC, INC. 510(k) NO: K003364(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 18-JUL-01
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADMIRA FLOW
VOCO GMBH 510(k) NO: K011756(TRADITIONAL)
ATTN: EVAN DICK PHONE NO : 314-721-0112
7527 WESTMORELAND AVE. SE DECISION MADE: 18-JUL-01
ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOXAR VC, MODEL 1.0
VOXAR LIMITED 510(k) NO: K012072(TRADITIONAL)
ATTN: CONRAD CHIN PHONE NO : 440 131 4724792
BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 12-JUL-01
EDINBURGH, UNITED KINGDOM EH6 5NP 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
WALTER LORENZ SURGICAL, INC. 510(k) NO: K011076(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 16-JUL-01
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELL-TENS
WELL-LIFE CONSULTANT 510(k) NO: K002874(TRADITIONAL)
ATTN: KEVIN CHIU PHONE NO : 886 429 72476
6CO1,NO.5.SEC.5,HSIN YI RD. SE DECISION MADE: 27-JUL-01
TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: METAL TRANSCEND ARTICULATION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K004043(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 13-JUL-01
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TES
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K011482(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 870 61486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 09-JUL-01
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR, MALAYSIA 43900
DEVICE: POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
XIROS PLC 510(k) NO: K010051(TRADITIONAL)
ATTN: JIM ROWLAND PHONE NO : 441 132 902600
28-30 BLENHEIM TERRACE SE DECISION MADE: 13-JUL-01
LEEDS, UNITED KINGDOM LS2 9HD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION
ZOLL MEDICAL CORP. 510(k) NO: K011865(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 800-242-9150
32 SECOND AVE. SE DECISION MADE: 31-JUL-01
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CA
ZYNERGY CARDIO VASULAR (ZCV), INC.510(k) NO: K011847(SPECIAL)
ATTN: JING ZHANG PHONE NO : 732-225-3800
298 FERNWOOD AVE. SE DECISION MADE: 13-JUL-01
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 283
TOTAL WITH SUMMARIES 203
TOTAL WITH STATEMENTS 80
Updated 8/21/2001
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