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510(k)s Final Decisions Rendered for August 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-AUG-2001 THROUGH 31-AUG-2001
DEVICE: 3T L. V. CONTROL VALVE
3T MEDICAL SYSTEMS, LLC. 510(k) NO: K001245(TRADITIONAL)
ATTN: TIMOTHY J SIMMONS PHONE NO : 248-879-6968
6770 PINE WAY DRIVE SE DECISION MADE: 15-AUG-01
TROY, MI 48098 510(k) STATEMENT
DEVICE: FUTURA TOPCAP NON GAMMA-2
AB ARDENT 510(k) NO: K011801(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE SE DECISION MADE: 16-AUG-01
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: TRS-2000 POWER TILT/POWER RECLINE SYSTEM
ACCELERATED REHAB DESIGNS, INC. 510(k) NO: K012281(TRADITIONAL)
ATTN: RANDALL POTTER PHONE NO : 281-356-1950
32025 INDUSTRIAL PARK DR. SE DECISION MADE: 01-AUG-01
PINEHURST, TX 77362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERKNIFE SYSTEM
ACCURAY, INC. 510(k) NO: K011024(TRADITIONAL)
ATTN: E. BRUCE FLOYD PHONE NO : 408-522-3740
570 DEL REY AVE. SE DECISION MADE: 10-AUG-01
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PH
ACON LABORATORIES, INC. 510(k) NO: K011730(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 09-AUG-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIK-CHECK HOME PREGNANCY TEST
ACON LABORATORIES, INC. 510(k) NO: K012215(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 07-AUG-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIK-CHECK OVULATION PREDICTOR
ACON LABORATORIES, INC. 510(k) NO: K012252(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO :
163 CABOT STREET SE DECISION MADE: 24-AUG-01
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K011962(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 44 146 067925
4 HOLYROOD STREET SE DECISION MADE: 09-AUG-01
CHARD, SOMERSET, UNITED KINGDOM TA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
AESCULAP, INC. 510(k) NO: K011102(TRADITIONAL)
ATTN: LISA M MILLINGTON PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 03-AUG-01
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
AESCULAP, INC. 510(k) NO: K011372(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 01-AUG-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K011721(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 14-AUG-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K012080(ABBREVIATED)
ATTN: KELVIN BURROUGHS PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 29-AUG-01
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K012253(ABBREVIATED)
ATTN: KELVIN BURROUGHS PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 30-AUG-01
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPREMCAST
AMERICAN DENT-ALL, INC. 510(k) NO: K011705(TRADITIONAL)
ATTN: VACHAKAN H KHOIE PHONE NO : 818-662-0618
5140 SAN FERNANDO ROAD SE DECISION MADE: 03-AUG-01
GLENDALE, CA 91204 510(k) STATEMENT
DEVICE: FLEXICAST PRIME
AMERICAN DENT-ALL, INC. 510(k) NO: K011706(TRADITIONAL)
ATTN: VACHAKAN H KHOIE PHONE NO : 818-662-0618
5140 SAN FERNANDO ROAD SE DECISION MADE: 06-AUG-01
GLENDALE, CA 91204 510(k) STATEMENT
DEVICE: GULLIVER AND CLASSE A
AMERICAN DENTAL TECHNOLOGIES, INC.510(k) NO: K012213(TRADITIONAL)
ATTN: JOHN VICKERS PHONE NO : 361-289-1145
5555 BEAR LANE SE DECISION MADE: 13-AUG-01
CORPUS CHRISTI, TX 78405 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K011251(TRADITIONAL)
ATTN: GINGER S GLASER PHONE NO : 952-930-6541
10700 BREN RD., WEST SE DECISION MADE: 01-AUG-01
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ SET INFUSION SET
ANIMAS CORP. 510(k) NO: K012754(TRADITIONAL)
ATTN: MICHAEL J ANDREWS PHONE NO : 610-644-8990
590 E. LANCASTER AVENUE SE DECISION MADE: 27-AUG-01
FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
APEX DENTAL MATERIALS, INC. 510(k) NO: K010544(TRADITIONAL)
ATTN: SCOTT LAMERAND PHONE NO : 847-490-1014
603 BERKLEY COURT SE DECISION MADE: 10-AUG-01
SCHUMBURG, IL 60194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX SEALAND L/C ORTHODONTIC SEALANT
APEX DENTAL MATERIALS, INC. 510(k) NO: K010547(TRADITIONAL)
ATTN: SCOTT LAMERAND PHONE NO : 847-490-1014
603 BERKLEY COURT SE DECISION MADE: 16-AUG-01
SCHUMBURG, IL 60194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MO
APEX MEDICAL CORP. 510(k) NO: K002339(TRADITIONAL)
ATTN: DANIEL LEE PHONE NO : 886 226 954122
10TH FL., NO. 31, LANE 169, SE DECISION MADE: 24-AUG-01
KANG NING ST. 510(k) SUMMARY AVAILABLE FROM FDA
HSI CHIH CHEN, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K012476(SPECIAL)
ATTN: CHRIS ZANTOPULOS PHONE NO : 216-475-5577
15653 NEO PKWY. SE DECISION MADE: 31-AUG-01
CLEVELAND, OH 44128 510(k) STATEMENT
DEVICE: MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHE
APPRIVA MEDICAL, INC. 510(k) NO: K012489(SPECIAL)
ATTN: MICHAEL KOLBER PHONE NO : 408-616-5203
777 NORTH PASTORIA AVE. SE DECISION MADE: 30-AUG-01
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX BIO-POST AND WASHER
ARTHREX, INC. 510(k) NO: K011495(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 01-AUG-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
ASTRA TECH, INC. 510(k) NO: K012374(SPECIAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
96 WEST MAIN STREET SE DECISION MADE: 23-AUG-01
NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE BIPOLAR COAGULATION SYSTEM
ATRICURE, INC. 510(k) NO: K011722(TRADITIONAL)
ATTN: MARK L FRIEDMAN PHONE NO : 513-755-4105
6033 SCHUMACHER PARK DRIVE SE DECISION MADE: 30-AUG-01
WEST CHESTER, OHIO, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
ATYS MEDICAL 510(k) NO: K012369(TRADITIONAL)
ATTN: CHRISTINE TURLAT PHONE NO : 33 4 78056969
17, PARC D' ARBORA SE DECISION MADE: 10-AUG-01
SOUCIEU EN JARREST, FRANCE 69510 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
AXYA MEDICAL, INC. 510(k) NO: K011912(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 31-AUG-01
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL
BASIC DENTAL IMPLANT SYSTEMS, INC.510(k) NO: K012299(SPECIAL)
ATTN: DAN BLACKLOCK PHONE NO : 505-881-1376
3321 COLUMBIA, N.E. SE DECISION MADE: 01-AUG-01
ALBUQUERQUE, NM 87107-2001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUMER LOCKING NAIL
BAUMER S.A. 510(k) NO: K011504(TRADITIONAL)
ATTN: BRENO CORREA FARAGO JR. PHONE NO : 551 938 063030
AV. PREF. ANTONIO TAVARES SE DECISION MADE: 14-AUG-01
LEITE NR: 181 510(k) STATEMENT
MOGI MIRIM, SAO PAULO, BRAZIL 13800-000
DEVICE: BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
BAYER CORP. 510(k) NO: K010755(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 20-AUG-01
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
BECTON DICKINSON & CO. 510(k) NO: K011984(TRADITIONAL)
ATTN: M. WENDY BOSSHARDT PHONE NO : 201-847-6280
1 BECTON DRIVE SE DECISION MADE: 29-AUG-01
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "SNOW LOTUS" POWDER-FREE LATEX SURGEON'S GLOVES
BEIJING REAGENT LATEX PRODUCTS 510(k) NO: K012104(TRADITIONAL)
ATTN: WANG YANNAN PHONE NO : 86 10 81502573
NO. 30 SOUTH SANLITUN ROAD, SE DECISION MADE: 21-AUG-01
DONGDAQIAO 510(k) SUMMARY AVAILABLE FROM FDA
CHAOWAI, BEIJING, P.R., CHINA 100020
DEVICE: NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
BEST MANUFACTURING COMPANY 510(k) NO: K012166(TRADITIONAL)
ATTN: DAVID C YOUNG PHONE NO : 706-862-2302
579 EDISON STREET SE DECISION MADE: 01-AUG-01
MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL
BIO-RAD LABORATORIES 510(k) NO: K012513(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 29-AUG-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB RAPIDFLAP
BIOMET, INC. 510(k) NO: K003281(TRADITIONAL)
ATTN: CAROL LAUSTER PHONE NO : 219-372-1913
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 07-AUG-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: INTERLOK / HA COPELAND RESURFACING HEADS
BIOMET, INC. 510(k) NO: K010635(TRADITIONAL)
ATTN: MARY L VERSTYNEN PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-AUG-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MAXIM RPG PS FEMORAL COMPONENT
BIOMET, INC. 510(k) NO: K012348(SPECIAL)
ATTN: MICHELLE MCKINLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 15-AUG-01
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA
BIONOSTICS, INC. 510(k) NO: K012430(TRADITIONAL)
ATTN: KATHY STORRO PHONE NO : 978-263-3856
2 CRAIG RD. SE DECISION MADE: 27-AUG-01
ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MU
BIONOSTICS, INC. 510(k) NO: K012431(TRADITIONAL)
ATTN: KATHY STORRO PHONE NO : 978-263-3856
2 CRAIG RD. SE DECISION MADE: 28-AUG-01
ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WUJIN #3 FEMORAL BONE PLATE
BIOPRO, INC. 510(k) NO: K011459(TRADITIONAL)
ATTN: PATRICK PRINGLE PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 07-AUG-01
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WUJIN #3 TIBIAL BONE PLATE
BIOPRO, INC. 510(k) NO: K011460(TRADITIONAL)
ATTN: PATRICK PRINGLE PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 07-AUG-01
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDYBELL
BIOPSYBELL S.A.S. 510(k) NO: K010735(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 860-633-8807
131 HIGHWOOD DRIVE SE DECISION MADE: 17-AUG-01
SOUTH GLASTONBURY, CT 06073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-SCAN MRI SYSTEM
BIOSOUND ESAOTE, INC. 510(k) NO: K012728(SPECIAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 29-AUG-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRAL VENOUS CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K003839(TRADITIONAL)
ATTN: THERESA A MCGOVERN PHONE NO : 508-652-5430
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 01-AUG-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACK-UP MEIER GUIDEWIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K011906(TRADITIONAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 508-652-5008
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 13-AUG-01
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL DIALYSIS CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K012365(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 24-AUG-01
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIROYAL BILIARY PREMOUNTED STENT SYSTEM
BOSTON SCIENTIFIC/SCIMED 510(k) NO: K012216(SPECIAL)
ATTN: CANDICE BURNS PHONE NO : 763-494-2845
ONE SCIMED PLACE SE DECISION MADE: 17-AUG-01
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION CT/FLUORO
BRAINLAB, AG 510(k) NO: K010968(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 30-AUG-01
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG-3250 MINIRECEIVER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K012187(SPECIAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 14-AUG-01
REHOVOT, ISRAEL 76100 510(k) STATEMENT
DEVICE: CERVILENZ UTERINE MEASURING SOUND
CERVILENZ INC 510(k) NO: K011840(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 10-AUG-01
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHASE CARDIOVASCULAR PATCH
CHASE MEDICAL, INC. 510(k) NO: K012248(TRADITIONAL)
ATTN: DAVE JERNON PHONE NO : 972-783-0644
1704 ENTERPRISE DR. SE DECISION MADE: 10-AUG-01
ATHENS, TX 75751 510(k) STATEMENT
DEVICE: HCG STAT PAK ULTRA-FAST
CHEMBIO DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K011550(SPECIAL)
ATTN: FRAN WHITE PHONE NO : 987-927-3808
163 CABOT STREET SE DECISION MADE: 14-AUG-01
BEVERLY,, MA 01915 510(k) STATEMENT
DEVICE: SURE CHECK PREGNANCY TEST
CHEMBIO DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K011551(SPECIAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 14-AUG-01
BEVERLY,, MA 01915 510(k) STATEMENT
DEVICE: QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUI
CHRONIMED, INC. 510(k) NO: K010039(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 612-974-4088
6214 BURY DR. SE DECISION MADE: 10-AUG-01
EDEN PRAIRIE, MN 55346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAY-PARK LABS, INC. - LUBRICATING JELLY
CLAY-PARK LABS, INC. 510(k) NO: K012203(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVE., N.W. SE DECISION MADE: 27-AUG-01
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUISPX LIQUID LIPID CONTROL
CLINICAL CONTROLS DIVISION 510(k) NO: K012855(TRADITIONAL)
ATTN: JAMES F GODFREY PHONE NO : 562-809-3389
12038 CENTRALIA AVE. SE DECISION MADE: 30-AUG-01
UNIT C 510(k) STATEMENT
HAWAIIAN GARDENS, CA 90716
DEVICE: COALESCENT SURGICAL U-CLIP
COALESCENT SURGICAL 510(k) NO: K012317(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 31-AUG-01
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN DENTAL MEMBRANE
COLLAGEN MATRIX, INC. 510(k) NO: K011695(TRADITIONAL)
ATTN: SHU-TUNG LI PHONE NO : 201-405-1477
509 COMMERCE STREET SE DECISION MADE: 07-AUG-01
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK ZILVER BILIARY STENT
COOK, INC. 510(k) NO: K010242(TRADITIONAL)
ATTN: LISA HOPKINS PHONE NO : 812-339-0489
925 SOUTH CURRY PIKE SE DECISION MADE: 13-AUG-01
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
CORDIS CORP. 510(k) NO: K010411(ABBREVIATED)
ATTN: CHARLES J RYAN PHONE NO : 908-412-7446
7 POWDERHORN DRIVE SE DECISION MADE: 27-AUG-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
CORDIS CORP. 510(k) NO: K012087(SPECIAL)
ATTN: CHUCK RYAN PHONE NO : 908-412-7446
14201 N.W. 60TH AVE. SE DECISION MADE: 01-AUG-01
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018
CORDIS EUROPA N.V. 510(k) NO: K012056(SPECIAL)
ATTN: CHUCK RYAN PHONE NO : 908-412-7446
7 POWDER HORN DRIVE SE DECISION MADE: 01-AUG-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
CORDIS, A JOHNSON & JOHNSON CO. 510(k) NO: K012090(SPECIAL)
ATTN: CHARLES J RYAN PHONE NO : 908-412-7446
7 POWDER HORN DRIVE SE DECISION MADE: 01-AUG-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUA
CORGENIX, INC. 510(k) NO: K012567(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 23-AUG-01
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: 8100/8500 VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC. 510(k) NO: K012059(SPECIAL)
ATTN: ALEX KAPLAN PHONE NO : 262-798-8282
20925 CROSSROADS CIRCLE SE DECISION MADE: 01-AUG-01
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOPLAN SYSTEM
CRYOMEDICAL SCIENCES, INC. 510(k) NO: K011073(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 22-AUG-01
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
CYPRESS MEDICAL PRODUCTS, LTD. 510(k) NO: K012282(TRADITIONAL)
ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100
1202 SOUTH ROUTE 31 SE DECISION MADE: 06-AUG-01
MCHENRY, IL 60050 510(k) STATEMENT
DEVICE: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
DADE BEHRING, , INC. 510(k) NO: K010418(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BLVD. SE DECISION MADE: 22-AUG-01
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCT SYSTEM
DADE BEHRING, INC. 510(k) NO: K011665(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
P.O. BOX 6101 SE DECISION MADE: 09-AUG-01
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUASENS FLUID MONITORING SYSTEM
DAVOL, INC., SUB. C.R. BARD, INC. 510(k) NO: K011069(TRADITIONAL)
ATTN: LUCINDA L FOX PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 16-AUG-01
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CERCON CERAM
DEGUSSA - NEY DENTAL, INC. 510(k) NO: K011333(TRADITIONAL)
ATTN: THOMAS C CAMERON PHONE NO : 800-243-1942
65 WEST DUDLEY TOWN RD. SE DECISION MADE: 20-AUG-01
BLOOMFIELD, CT 06002 510(k) STATEMENT
DEVICE: HI-WAVE; POUR-PLUS
DENPLUS, INC. 510(k) NO: K011762(TRADITIONAL)
ATTN: SHUOJIA DONG PHONE NO : 450 646 1330
1221 LABADIE, SUITE 205 SE DECISION MADE: 23-AUG-01
LONGUEUIL, QUEBEC, CANADA J4N 1E2 510(k) STATEMENT
DEVICE: IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012311(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 20-AUG-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012312(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 20-AUG-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K012053(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 20-AUG-01
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC240
DIATEK, INC. 510(k) NO: K010399(TRADITIONAL)
ATTN: TODD CASSIDY PHONE NO : 336-725-9711
101 N. CHESTNUTS ST. SE DECISION MADE: 14-AUG-01
WINSTON-SALEM, NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXACORE/LUXACORE DUAL
DMG USA, INC. 510(k) NO: K012307(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 23-AUG-01
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMACEM / PERMACEM DUAL
DMG USA, INC. 510(k) NO: K012316(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
414 SOUTH STATE STREET SE DECISION MADE: 23-AUG-01
DOVER, DE 19901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
DNI NEVADA, INC. 510(k) NO: K011729(TRADITIONAL)
ATTN: KRISTINE BOGGS PHONE NO : 775-883-3400
2000 ARROWHEAD DR. SE DECISION MADE: 30-AUG-01
CARSON CITY, NV 89706-0403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER LITHOTRIPTER S("DOLI S") & DORNIER LITHOTRIPTER S-XP ("D
DORNIER 510(k) NO: K011873(TRADITIONAL)
ATTN: SUZANNEW COURTNEY PHONE NO : 770-514-6204
1155 ROBERTS BOULEVARD SE DECISION MADE: 31-AUG-01
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT I
DR. IHDE DENTAL AG SWITZERLAND 510(k) NO: K991822(TRADITIONAL)
ATTN: MOURAD BARAKET PHONE NO : 212-217-2222
BATTERY PLACE 70, RIVERWATCH SE DECISION MADE: 15-AUG-01
SUITE 406 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10280
DEVICE: KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
EASTMAN KODAK COMPANY 510(k) NO: K012155(SPECIAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-724-4795
343 STATE ST. SE DECISION MADE: 10-AUG-01
ROCHESTER, NY 14650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
EBI, L.P. 510(k) NO: K011386(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 03-AUG-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K012445(SPECIAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 24-AUG-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
ELEKTA ONCOLOGY SYSTEMS, LTD. 510(k) NO: K012289(SPECIAL)
ATTN: PETER STEGAGNO PHONE NO : 770-300-9725
3155 NORTHWOODS PARKWAY SE DECISION MADE: 14-AUG-01
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILI
EMBRYOTECH LABORATORIES, INC. 510(k) NO: K011679(TRADITIONAL)
ATTN: ANN D MCGONIGLE PHONE NO : 508-358-9114
19 SEDGEMEADOW ROAD SE DECISION MADE: 15-AUG-01
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOGRAPHIC MARKERS
ENCORE ORTHOPEDICS, INC. 510(k) NO: K011856(TRADITIONAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 22-AUG-01
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:ENDIUS BIPOLAR SHEATH
ENDIUS, INC. 510(k) NO: K012488(SPECIAL)
ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 30-AUG-01
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
ETHICON ENDO-SURGERY, INC. 510(k) NO: K011538(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 09-AUG-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTECTIV ACUVANCE IV CATHETER SYSTEM
ETHICON ENDO-SURGERY, INC. 510(k) NO: K012128(TRADITIONAL)
ATTN: KATIE FORDYCE PHONE NO : 513-337-8995
4545 CREEK RD. SE DECISION MADE: 01-AUG-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
EXACTECH, INC. 510(k) NO: K012493(SPECIAL)
ATTN: ROBERT PAXSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 29-AUG-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCEL I.V. ADMINISTRATION SET
EXELINT INTL. CO. 510(k) NO: K010404(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
P.O. BOX 3194 SE DECISION MADE: 30-AUG-01
CULVER CITY, CA 90231-3194 510(k) STATEMENT
DEVICE: INSIGHT GENESIS
FASSTECH 510(k) NO: K011983(TRADITIONAL)
ATTN: LEE BRODY PHONE NO : 781-229-1500
155 MIDDLESEX TURNPIKE SE DECISION MADE: 30-AUG-01
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
FERRANIA S.P.A. 510(k) NO: K012373(TRADITIONAL)
ATTN: MANNELA PAOLO PHONE NO : 390 195 221
57 VIALE DELLA LIBERTA SE DECISION MADE: 09-AUG-01
FERRANIA, SAVONA, ITALY 17014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICRO TARGETING DRIVE SYSTEM
FHC, INC. 510(k) NO: K011775(TRADITIONAL)
ATTN: FREDERICK HAER PHONE NO : 207-666-8190
9 MAIN STREET SE DECISION MADE: 30-AUG-01
BOWDOINHAM, ME 04008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FHC MICROTARGETING DRIVE SYSTEM
FHC, INC. 510(k) NO: K011992(SPECIAL)
ATTN: FREDERICK HAER PHONE NO : 207-666-8190
9 MAIN STREET SE DECISION MADE: 14-AUG-01
BOWDOINHAM, ME 04008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO VLC; ORTHO VLC CAPSULE
FIRST SCIENTIFIC LIMITED 510(k) NO: K011521(TRADITIONAL)
ATTN: ADE AKINMADE PHONE NO : 44 149 5320456
7 ROSEHEYWORTH BUSINESS PARK SE DECISION MADE: 01-AUG-01
ABERTILLERY 510(k) STATEMENT
BLAENAU GWENT, WALES, UNITED KINGDOM NP13 1SP
DEVICE: FLEX-NAILS
FIXANO SA 510(k) NO: K012161(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O BOX 12038 SE DECISION MADE: 24-AUG-01
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS CO
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K012242(SPECIAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE. SE DECISION MADE: 16-AUG-01
LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
GAMBRO RENAL PRODUCTS 510(k) NO: K011368(TRADITIONAL)
ATTN: FEI LAW PHONE NO : 904-274-2811
1845 MASON AVE. SE DECISION MADE: 02-AUG-01
DAYTONA BEACH, FL 32117-5102 510(k) STATEMENT
DEVICE: GPW-SF
GATEWAY ALLOYS, INC. 510(k) NO: K011659(TRADITIONAL)
ATTN: JOHN C CONSTANTINE PHONE NO : 888-357-7291
1702 SCHERER PKWY. SE DECISION MADE: 27-AUG-01
ST. CHARLES, MO 63303 510(k) STATEMENT
DEVICE: CONCORD 88
GATEWAY ALLOYS, INC. 510(k) NO: K011661(ABBREVIATED)
ATTN: JOHN C CONSTANTINE PHONE NO : 888-357-7291
1702 SCHERER PKWY. SE DECISION MADE: 27-AUG-01
ST. CHARLES, MO 63303 510(k) STATEMENT
DEVICE: GC E-LIGHT
GC AMERICA, INC. 510(k) NO: K012134(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 07-AUG-01
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: ADVANCED HIP ASSESSMENT SOFTWARE
GE LUNAR CORP. 510(k) NO: K011917(TRADITIONAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 03-AUG-01
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE SIGNA 1.5T TWINSPEED MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K012200(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 03-AUG-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K011604(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 22-AUG-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT COLONOGRAPHY/NAVIGATOR2
GE MEDICAL SYSTEMS, INC. 510(k) NO: K012313(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 07-AUG-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HISPEED X/I SMART GANTRY OPTION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K012385(TRADITIONAL)
ATTN: JOHN W JAECKLE PHONE NO : 262-785-5323
P.O. BOX 414 SE DECISION MADE: 10-AUG-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K012389(TRADITIONAL)
ATTN: JODI PARKER PHONE NO : 262-548-4964
P.O. BOX 414 SE DECISION MADE: 10-AUG-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORA
GEBAUER CO. 510(k) NO: K981693(TRADITIONAL)
ATTN: DENISE E SPELLMAN PHONE NO : 216-271-5252
9410 ST. CATHERINE AVE. SE DECISION MADE: 06-AUG-01
CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRIT
GELFLEX 510(k) NO: K011072(TRADITIONAL)
ATTN: PETER G BRYANT PHONE NO : 618 944 34944
THREE HUTTON STREET SE DECISION MADE: 24-AUG-01
OSBORNE PARK 510(k) SUMMARY AVAILABLE FROM FDA
PERTH, AUSTRALIA 6017
DEVICE: GE LOGIQ A100 MP, MODEL 2272413
GENERAL ELECTRIC CO. 510(k) NO: K012560(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 23-AUG-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENZYME DIRECT-AMYLASE TEST REAGENT
GENZYME CORP. 510(k) NO: K011843(TRADITIONAL)
ATTN: BARBARA PIZZA PHONE NO : 617-252-7953
ONE KENDALL SQUARE SE DECISION MADE: 10-AUG-01
CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIBBONS STERILE TROCAR KITS
GIBBONS SURGICAL CORP. 510(k) NO: K012198(SPECIAL)
ATTN: LISA CRISSON PHONE NO : 757-491-7305
1112 JENSEN DRIVE, STE.101 SE DECISION MADE: 09-AUG-01
VIRGINIA BEACH, VA 23451 510(k) STATEMENT
DEVICE: GSIBP BLOOD PRESSURE CUFF
GLOBAL SHOP, INC. 510(k) NO: K012553(ABBREVIATED)
ATTN: GARY C BAUMAN PHONE NO : 201-444-7204
1156 EAST RIDGEWOOD AVE. SE DECISION MADE: 17-AUG-01
PO BOX 1211 510(k) SUMMARY AVAILABLE FROM FDA
RIDGEWOOD, NJ 07450 THIRD PARTY REVIEW
DEVICE: INFANT OXYGEN TREATMENT HOOD
GULF COAST HYPERBARICS, INC. 510(k) NO: K011565(TRADITIONAL)
ATTN: JAMES W MCCARTHY PHONE NO : 904-769-2545
4309 GREEN LEAF CIRCLE SE DECISION MADE: 16-AUG-01
PANAMA CITY, FL 32404 510(k) STATEMENT
DEVICE: MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD. 510(k) NO: K012310(SPECIAL)
ATTN: SUSAN CHEN PHONE NO : 886 2 32349600
6F,NO. 407, CHUNG SHAN RD. SE DECISION MADE: 22-AUG-01
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: MUSCLE STIMULATOR SA-100
HEALTH@FITNESS TECHNOLOGIES, INC. 510(k) NO: K010807(TRADITIONAL)
ATTN: IVAN VRDOLJAK PHONE NO : 385 213 85828
KARAMANOVA 11 SE DECISION MADE: 09-AUG-01
21000 SPLIT, CROATIA 21000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHILLIT
HEATSHIELD, INC. 510(k) NO: K011666(TRADITIONAL)
ATTN: WILLIAM A PLOUMIS PHONE NO : 914-235-0590
110 LOCKWOOD AVE. SE DECISION MADE: 06-AUG-01
SUITE 400 510(k) STATEMENT
NEW ROCHELLE, NY 10801
DEVICE: MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
HEMATRONIX, INC. 510(k) NO: K012243(TRADITIONAL)
ATTN: JAMES S AFRANKO PHONE NO : 707-746-7833
524 STONE RD. SE DECISION MADE: 20-AUG-01
SUITE A 510(k) STATEMENT
BENICIA, CA 94510
DEVICE: TRANSLUX ENERGY
HERAEUS KULZER, INC. 510(k) NO: K012341(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 30-AUG-01
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000
HITACHI MEDICAL CORP. 510(k) NO: K012239(TRADITIONAL)
ATTN: WALTER WEYBURNE PHONE NO : 914-524-9711
660 WHITE PLAINS ROAD SE DECISION MADE: 10-AUG-01
TARRYTOWN, NY 10591-5107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K011320(TRADITIONAL)
ATTN: ROBERT H MCCARTHY PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 09-AUG-01
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMEDA HYGIENIKIT
HOLLISTER, INC. 510(k) NO: K011519(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 15-AUG-01
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZONS INTERNATIONAL POLYPECTOMY SNARES
HORIZONS INTL. CORP. 510(k) NO: K011667(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
P.O. BOX 7273 SE DECISION MADE: 16-AUG-01
PONCE, PR 00732-7273 510(k) STATEMENT
DEVICE: MODIFICATION TO: LONG LENGTH GAMMA NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K012158(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 01-AUG-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PLATING SYSTEM BASIC FRAGMENT SET
HOWMEDICA OSTEONICS CORP. 510(k) NO: K012162(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 31-AUG-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
I-STAT CORP. 510(k) NO: K012478(SPECIAL)
ATTN: PAUL VANDERWERF PHONE NO : 609-469-0242
104 WINDSOR CENTER DR. SE DECISION MADE: 20-AUG-01
EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K011971(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD SE DECISION MADE: 03-AUG-01
SUITE 210 510(k) STATEMENT
MELBOURNE, FL 32935
DEVICE: ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
IMAGING SERVICES, INC. 510(k) NO: K010772(TRADITIONAL)
ATTN: DEAN JAMES PHONE NO : 800-900-9729
8210 LANKERSHIM BLVD., #1 SE DECISION MADE: 23-AUG-01
NORTH HOLLOYWOOD, CA 91605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
IMAGYN SURGICAL 510(k) NO: K011575(TRADITIONAL)
ATTN: JULIE POWELL PHONE NO : 616-629-5811
8850 M-89 SE DECISION MADE: 17-AUG-01
PO BOX 351 510(k) SUMMARY AVAILABLE FROM FDA
RICHLAND, MI 49083
DEVICE: VIEWSTATION
IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K011694(TRADITIONAL)
ATTN: THOMAS H FARIS PHONE NO : 650-623-8807
100 WEST EVELYN AVE. SE DECISION MADE: 29-AUG-01
MOUNTAIN VIEW, CA 94041-1464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODEL
IMPLEX CORP. 510(k) NO: K012507(SPECIAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 30-AUG-01
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INPULSE DENTAL LASER
INCISIVE, LLC. 510(k) NO: K011423(TRADITIONAL)
ATTN: MICHAEL YESSIK PHONE NO : 510-669-9401
3095 RICHMOND PARKWAY SE DECISION MADE: 07-AUG-01
SUITE 213 510(k) SUMMARY AVAILABLE FROM FDA
RICHMOND, CA 94806
DEVICE: STRAUMANN GBR SYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K011698(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 23-AUG-01
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: ITI DENTAL IMPLANT SYSTEM
INSTITUT STRAUMANN SA 510(k) NO: K003552(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
1601 TRAPELO ROAD SE DECISION MADE: 17-AUG-01
RESERVOIR PLACE 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: OSSTELL RESONANCE FREQUENCY ANALYZER
INTEGRATION DIAGNOSTICS LTD 510(k) NO: K003714(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 09-AUG-01
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEO STRUCTURE
INTERPORE CROSS INTL. 510(k) NO: K010530(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 03-AUG-01
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT BILIRUBIN REAGENT
INTERSECT SYSTEMS, INC. 510(k) NO: K011972(TRADITIONAL)
ATTN: MARK E LEGAZ PHONE NO : 360-577-1062
P.O. BOX 2219 SE DECISION MADE: 27-AUG-01
LONGVIEW, WA 98632 510(k) STATEMENT
DEVICE: INTRALASE 600C LASER KERATOME
INTRALASE CORP. 510(k) NO: K002890(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
18732 SAGINAW SE DECISION MADE: 09-AUG-01
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILT SUPPORT CATHETER .014", MODEL C114LW1; ILT SUPPORT CATHETER
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K012169(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 30-AUG-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
INTRATHERAPEUTICS, INC. 510(k) NO: K011184(SPECIAL)
ATTN: AMY PETERSON PHONE NO : 612-697-2076
651 CAMPUS DR. SE DECISION MADE: 13-AUG-01
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
INVACARE CORP. 510(k) NO: K012167(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6000
ONE INVACARE WAY SE DECISION MADE: 01-AUG-01
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: SOLARA JR. MANUAL WHEELCHAIR
INVACARE CORP. 510(k) NO: K012370(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 03-AUG-01
PO BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44035
DEVICE: OSMED TISSUE EXPANDER
IOP, INC. 510(k) NO: K010852(TRADITIONAL)
ATTN: JASON MALECKA PHONE NO : 714-549-1185
3151 AIRWAY AVE., BLDG. I-1 SE DECISION MADE: 13-AUG-01
COSTA MESA, CA 92626 510(k) STATEMENT
DEVICE: HELIOSEAL CLEAR CHROMA
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K011491(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 16-AUG-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: ERIS LAYERING MATERIALS
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K012174(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 27-AUG-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JEL-20
J.F. JELENKO & CO., INC. 510(k) NO: K012303(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 22-AUG-01
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: JAS URIC ACID LIQUID REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K012038(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 21-AUG-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: FIRST FILL R.C.S.
JENERIC/PENTRON, INC. 510(k) NO: K011748(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 03-AUG-01
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: AVANTE MICRO CRYSTAL SYSTEM
JENERIC/PENTRON, INC. 510(k) NO: K012231(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NO.PLAINES INDUSTRIAL ROAD SE DECISION MADE: 23-AUG-01
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET THERAPY
JET THERAPY 510(k) NO: K002908(TRADITIONAL)
ATTN: OWEN B LAMB PHONE NO : 520-572-8414
12948 NORTH EAGLE MESA PLACE SE DECISION MADE: 30-AUG-01
MARANA, AZ 85653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY D-DIMER CONTROLS
KAMIYA BIOMEDICAL CO. 510(k) NO: K012422(TRADITIONAL)
ATTN: DON TRAN PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 21-AUG-01
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K010345(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 03-AUG-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA DION-GRACIA SET
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K010785(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 21-AUG-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
KENCAP LTD. 510(k) NO: K011514(TRADITIONAL)
ATTN: MARTY DELIN PHONE NO : 973-962-4844
247 MARGARET KING AVENUE SE DECISION MADE: 13-AUG-01
RINGWOOD, NJ 07456 510(k) STATEMENT
DEVICE: OLYMPUS SUCTION PUMP, MODEL KV-5
KEYMED (MEDICAL & INDUSTRIAL EQUIP510(k) NO: K011725(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 44 170 2444276
STOCK RD. SE DECISION MADE: 31-AUG-01
SOUTHEND-ON-SEA, ESSEX, UNITED KIN510(k) STATEMENT
DEVICE: DISPO ETCH
KIS PRODUCTS 510(k) NO: K984380(TRADITIONAL)
ATTN: REUBEN HERTZ PHONE NO : 954-764-0270
2318 SEA ISLAND DR. SE DECISION MADE: 06-AUG-01
FT. LAUDERDALE, FL 33301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPODRILL
KIS PRODUCTS 510(k) NO: K993124(TRADITIONAL)
ATTN: REUBEN HERTZ PHONE NO : 954-764-4074
2318 SEA ISLAND DR. SE DECISION MADE: 06-AUG-01
FT. LAUDERDALE, FL 33301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOPROPHY
KIS PRODUCTS 510(k) NO: K993182(TRADITIONAL)
ATTN: REUBEN HERTZ PHONE NO : 954-764-4074
2318 SEA ISLAND DR. SE DECISION MADE: 06-AUG-01
FT. LAUDERDALE, FL 33301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XUB EXTERNAL ULTRASOUND
KMI KOLSTER METHODS, INC. 510(k) NO: K010702(TRADITIONAL)
ATTN: ALWIN H KOLSTER PHONE NO : 714-956-1964
1170 N. GILBERT ST. SE DECISION MADE: 09-AUG-01
ANAHEIM, CA 92801 510(k) STATEMENT
DEVICE: AUTOMATED WORKCELL CONTROL SOFTWARE
LAB-INTERLINK, INC. 510(k) NO: K010500(TRADITIONAL)
ATTN: DEBORAH S KIPP PHONE NO : 402-595-3767
1011 SOUTH SADDLE CREEK RD. SE DECISION MADE: 01-AUG-01
OMAHA, NE 68106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
LATEXX PARTNERS BHD. 510(k) NO: K011791(TRADITIONAL)
ATTN: CHRISTINA SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 01-AUG-01
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAM
LATEXX PARTNERS BHD. 510(k) NO: K011792(TRADITIONAL)
ATTN: CHRISTINA SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 01-AUG-01
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTLAS 532 PHOTOCOAGULATOR
LIGHTMED CORP. 510(k) NO: K010372(TRADITIONAL)
ATTN: GARY LEE PHONE NO : 886 226 881726
NO.1-1, LANE1,PAO-AN ST. SEC.3 SE DECISION MADE: 22-AUG-01
SHULIN CITY, CHINA (TAIWAN) 238 510(k) STATEMENT
DEVICE: REUSABLE GLASS SYRINGES
LOCKETT MEDICAL CORP. 510(k) NO: K011176(TRADITIONAL)
ATTN: WILLIAM LOCKETT III PHONE NO : 401-421-6599
THREE RICHMOND SQUARE SE DECISION MADE: 10-AUG-01
PROVIDENCE, RI 02906 510(k) STATEMENT
DEVICE: LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENG
LUMENIS 510(k) NO: K011703(TRADITIONAL)
ATTN: LISA MCGRATH PHONE NO : 408-764-3604
2400 CONDENSA STREET SE DECISION MADE: 29-AUG-01
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROPORE IB RESORBABLE PLUG
MACROPORE, INC. 510(k) NO: K011715(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6740 TOP GUN ST. SE DECISION MADE: 27-AUG-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MB 11
MAICO DIAGNOSTIC GMBH 510(k) NO: K011746(TRADITIONAL)
ATTN: DANIEL E EGGAN PHONE NO : 952-941-4200
9675 WEST 76TH STREET SE DECISION MADE: 24-AUG-01
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
MAINE STANDARDS CO. 510(k) NO: K012117(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 20-AUG-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
MAINE STANDARDS CO. 510(k) NO: K012118(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 20-AUG-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
MAINE STANDARDS CO. 510(k) NO: K012119(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 20-AUG-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
MAINE STANDARDS CO. 510(k) NO: K012120(TRADITIONAL)
ATTN: CHRISTINE V BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 20-AUG-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
MAINE STANDARDS CO. 510(k) NO: K012122(TRADITIONAL)
ATTN: CHRISTINE V BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 20-AUG-01
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOALA CLAMP, KOALA CLAMP AND CUTTER
MATERNUS, INC. 510(k) NO: K011621(TRADITIONAL)
ATTN: RONALD B HICKS PHONE NO : 210-479-4001
P.O. BOX 782089 SE DECISION MADE: 10-AUG-01
SAN ANTONIO, TX 78278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAVIDON MEDICAL ELECTRODE JELLY
MAVIDON MEDICAL PRODUCTS 510(k) NO: K003924(TRADITIONAL)
ATTN: TIM CARROLL PHONE NO : 800-654-0385
2105 7TH AVE. NO. SE DECISION MADE: 24-AUG-01
LAKE WORTH, FL 33461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNIPER ELITE MODEL-OR-E3872XX SERIES
MAXXIM MEDICAL 510(k) NO: K011905(SPECIAL)
ATTN: GAIL DOHERTY PHONE NO : 903-675-9321
1445 FLAT CREEK ROAD SE DECISION MADE: 28-AUG-01
ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
MEDICAL ADVANCES, INC. 510(k) NO: K011608(TRADITIONAL)
ATTN: MICHAEL J LEIGH PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 14-AUG-01
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMP 3
MEDICAL SOLUTIONS, INC. 510(k) NO: K012276(TRADITIONAL)
ATTN: BRUCE HEYMANN PHONE NO : 703-736-1639
3901 CENTERVIEW DR., SUITE W SE DECISION MADE: 20-AUG-01
CHANTILLY, VA 20151 510(k) STATEMENT
DEVICE: MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
MEDICON, E.G. 510(k) NO: K010908(TRADITIONAL)
ATTN: JOACHIM SCHMID PHONE NO : 49 746 220090
GAENSAECKER 15 SE DECISION MADE: 01-AUG-01
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICON YASARGIL CLIP APPLYING FORCEPS
MEDICON, E.G. 510(k) NO: K010910(TRADITIONAL)
ATTN: JOACHIM SCHMID PHONE NO : 49 746 220090
GAENSAECKER 15 SE DECISION MADE: 01-AUG-01
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M5T INSTANT FEVER THERMOMETER
MEDISIM LTD. 510(k) NO: K012217(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
117 AHUZAH STREET SE DECISION MADE: 01-AUG-01
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
MEDRAD, INC. 510(k) NO: K011991(SPECIAL)
ATTN: LORRAINE R FREDES PHONE NO : 800-633-7231
ONE MEDRAD DR. SE DECISION MADE: 21-AUG-01
INDIANOLA, PA 15051 510(k) STATEMENT
DEVICE: SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
MEDTECH SYSTEMS, INC. 510(k) NO: K001853(TRADITIONAL)
ATTN: GARY MILLER PHONE NO : 763-417-0598
4825 OLSON MEMORIAL HIGHWAY, SE DECISION MADE: 22-AUG-01
SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA
GOLDEN VALLEY, MN 55422
DEVICE: BRIDGE FX
MEDTRONIC AVE, INC. 510(k) NO: K011817(SPECIAL)
ATTN: JOHN RIOLO PHONE NO : 707-525-0111
2170 NORTHPOINT PARKWAY SE DECISION MADE: 22-AUG-01
SANTA ROSA, CA 95407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S043
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K002992(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 454 457 9000
16-18 TONSBAKKEN SE DECISION MADE: 15-AUG-01
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K011472(TRADITIONAL)
ATTN: TOVE KJAER PHONE NO : 454 457 9000
16-18 TONSBAKKEN SE DECISION MADE: 10-AUG-01
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K010918(TRADITIONAL)
ATTN: SHERRI L POCOCK PHONE NO : 425-867-4332
11811 WILLOWS RD., N.E. SE DECISION MADE: 23-AUG-01
REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K012255(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 01-AUG-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THREADED CEMENT RESTRICTOR (CR) TITANIUM
MEDTRONIC SOFAMOR DANEK, USA 510(k) NO: K011443(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 03-AUG-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
MEDTRONIC, INC. 510(k) NO: K010300(TRADITIONAL)
ATTN: PAM SCHAUB PHONE NO : 763-514-7277
800 53RD AVENUE, N.E. SE DECISION MADE: 01-AUG-01
COLUMBIA HEIGHTS, MN 55421-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
MEDTRONIC, INC. 510(k) NO: K012083(TRADITIONAL)
ATTN: KAREN REIDT PHONE NO : 763-514-3914
7000 CENTRAL AVE. N.E. SE DECISION MADE: 28-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
MEDTRONIC, INC. 510(k) NO: K012130(TRADITIONAL)
ATTN: KAREN REIDT PHONE NO : 763-514-3914
7000 CENTRAL AVENUE NE SE DECISION MADE: 28-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTAIN 6215 VENOGRAM BALLOON CATHETER
MEDTRONIC, INC. 510(k) NO: K012225(TRADITIONAL)
ATTN: KAREN REIDT PHONE NO : 763-514-3914
7000 CENTRAL AVENUE N.E. SE DECISION MADE: 28-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
MEDTRONIC, INC. 510(k) NO: K012452(SPECIAL)
ATTN: TINA BENOIT PHONE NO : 763-514-4112
7000 CENTRAL AVENUE NE SE DECISION MADE: 14-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
MEDTRONIC, INC. 510(k) NO: K012454(SPECIAL)
ATTN: TINA BENOIT PHONE NO : 763-514-4112
7000 CENTRAL AVENUE NE SE DECISION MADE: 14-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
MEDTRONIC, INC. 510(k) NO: K012458(SPECIAL)
ATTN: TINA BENOIT PHONE NO : 763-514-4112
7000 CENTRAL AVENUE NE SE DECISION MADE: 14-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
MEDTRONIC, INC. 510(k) NO: K012459(SPECIAL)
ATTN: TINA BENOIT PHONE NO : 763-514-4112
7000 CENTRAL AVENUE NE SE DECISION MADE: 14-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
MEDTRONIC, INC. 510(k) NO: K012460(SPECIAL)
ATTN: TINA BENOIT PHONE NO : 763-514-4112
7000 CENTRAL AVENUE NE SE DECISION MADE: 14-AUG-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
MEDTRONIC, INC. 510(k) NO: K012538(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 763-391-9183
7611 NORTHLAND DRIVE SE DECISION MADE: 23-AUG-01
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENVOY PATIENT MONITOR
MENNEN MEDICAL LTD. 510(k) NO: K011784(SPECIAL)
ATTN: ASHER KASSEL PHONE NO : 972 8 9383030
KIRYAT WEIZMANN SE DECISION MADE: 16-AUG-01
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K011811(SPECIAL)
ATTN: DAN REIGLE PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 22-AUG-01
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MP3U, POWER WHEELCHAIR
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K011513(ABBREVIATED)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 10-AUG-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: MP-3C POWER BASE CHAIR, MODEL MP3C
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K011687(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 03-AUG-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K011751(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 06-AUG-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K011753(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 03-AUG-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K011844(TRADITIONAL)
ATTN: LEE LEICHTER PHONE NO : 941-786-1118
7690 CAMERON CIRCLE SE DECISION MADE: 28-AUG-01
FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
MERITS MEDICAL INDUSTRIES CO., LTD510(k) NO: K011707(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O.BOX 150356 SE DECISION MADE: 03-AUG-01
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K011657(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 914-667-3999
521 HOMESTEAD AVENUE SE DECISION MADE: 27-AUG-01
MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE PRECISION INJECTOR, MODEL 103-0304
MICRO THERAPEUTICS, INC. 510(k) NO: K011535(ABBREVIATED)
ATTN: EBEN GORDON PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 02-AUG-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRULINE INFUSION CATHETERS
MICRO THERAPEUTICS, INC. 510(k) NO: K011937(SPECIAL)
ATTN: EBEN GORDON PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 28-AUG-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI ECSTASY URINE CALIBRATORS
MICROGENICS CORP. 510(k) NO: K012109(TRADITIONAL)
ATTN: SHERRIE RINNE PHONE NO : 510-979-5150
46360 FREMONT BLVD. SE DECISION MADE: 27-AUG-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI ECSTASY ENZYME IMMUNOASSAY
MICROGENICS CORP. 510(k) NO: K012110(TRADITIONAL)
ATTN: SHERRIE RINNE PHONE NO : 510-979-5150
46360 FREMONT BLVD. SE DECISION MADE: 27-AUG-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTIM 100I TENS DEVICE
MICROSTIM, INC. 510(k) NO: K010295(TRADITIONAL)
ATTN: JOEL ROSSEN PHONE NO : 954-720-4383
7881 N.W. 90TH AVE. SE DECISION MADE: 03-AUG-01
TAMARAC, FL 33321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUSCLE IMAGING SYSTEM (MIS)
MILLENNIUM MAGNETIC IMAGING, INC. 510(k) NO: K011416(TRADITIONAL)
ATTN: DONALD H MARKS PHONE NO : 205-283-1688
210 LORNA SQUARE, PMB 192 SE DECISION MADE: 06-AUG-01
HOOVER, AL 35216 510(k) STATEMENT
DEVICE: MBI PD-103 SL; MBI PD-103 SH
MILLS BIOPHARMACEUTICALS, INC. 510(k) NO: K011427(TRADITIONAL)
ATTN: STANLEY MILLS PHONE NO : 405-525-3141
120 N.E. 26TH ST. SE DECISION MADE: 31-AUG-01
OKLAHOMA CITY, OK 73105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
MINOLTA CO., LTD. 510(k) NO: K010413(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-838-8619
458 S. RANDOM ROAD SE DECISION MADE: 02-AUG-01
BAILEY, CO 80421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HNC-127 NEUROVASCULAR ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K012353(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 14-AUG-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: NEUROEDGE INFUSION CATHETER
NEURO VASX, INC. 510(k) NO: K011646(TRADITIONAL)
ATTN: JACK SLOVICK PHONE NO : 763-315-0013
7351 KIRKWOOD LANE, SUITE 112 SE DECISION MADE: 27-AUG-01
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
NEUROTRON MEDICAL, INC. 510(k) NO: K012069(SPECIAL)
ATTN: WHITT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 01-AUG-01
SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: AA-1 SYSTEM
NEUROVISION, INC. 510(k) NO: K012530(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 31-AUG-01
SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: THE SPIN SNAP-OFF SCREW
NEW DEAL, S.A. 510(k) NO: K011946(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 24-AUG-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE UNI-CLIP STAPLE
NEWDEAL S.A. 510(k) NO: K011716(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 30-AUG-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTWAVE IF 2000
NEWWAVE MEDICAL LLC. 510(k) NO: K003631(TRADITIONAL)
ATTN: ROBERT ARMSTRONG PHONE NO : 214-516-8383
620 HAGGARD ST. STE 614 SE DECISION MADE: 10-AUG-01
PLANO, TX 75074-5530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPERMCATCH
NIDACON INTERNATIONAL AB 510(k) NO: K011607(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 10-AUG-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIDOIL
NIDACON INTERNATIONAL AB 510(k) NO: K012123(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 03-AUG-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,405
NIKO MEDICAL PRODUCTS 510(k) NO: K003804(ABBREVIATED)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST SE DECISION MADE: 30-AUG-01
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELK LASER IMAGER, MODEL EL-DRY 4000
NISHIMOTO SANGYO CO., LTD. 510(k) NO: K011949(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 29-AUG-01
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
NON-INVASIVE MONITORING SYSTEMS, I510(k) NO: K012020(SPECIAL)
ATTN: ALLAN F BRACK PHONE NO : 305-534-3694
1840 WEST AVE. SE DECISION MADE: 21-AUG-01
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-0
NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K011928(TRADITIONAL)
ATTN: CASEY KUREK PHONE NO : 847-608-8900
600 CHURCH RD. SE DECISION MADE: 10-AUG-01
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE PHOX PLUS L ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K012058(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 20-AUG-01
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: DISPOSABLE VITRECTOMY LENS
OCULAR INSTRUMENTS, INC. 510(k) NO: K012096(TRADITIONAL)
ATTN: RAYMOND GRAHAM PHONE NO : 425-455-5200
2255 116TH AVE., N.E. SE DECISION MADE: 24-AUG-01
BELLEVUE, WA 98004-3039 510(k) STATEMENT
DEVICE: OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA UL
OLYMPUS AMERICA, INC. 510(k) NO: K011886(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 27-AUG-01
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K011484(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 10-AUG-01
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
OPUSDENT LTD. 510(k) NO: K011769(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 9 7718150
117 AHUZAH ST. SE DECISION MADE: 30-AUG-01
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VULCAN TAC PROBES, MODEL 911XXX
ORATEC INTERVENTIONS, INC. 510(k) NO: K003198(TRADITIONAL)
ATTN: LARAINE PANGELINA PHONE NO : 650-687-2621
3700 HAVEN CT. SE DECISION MADE: 29-AUG-01
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTAFLEX SURGICAL MESH
ORGANOGENESIS, INC. 510(k) NO: K011025(TRADITIONAL)
ATTN: PATRICK R BILBO PHONE NO : 781-401-1155
150 DAN RD. SE DECISION MADE: 24-AUG-01
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
ORIDION MEDICAL 1987 LTD. 510(k) NO: K012391(SPECIAL)
ATTN: SANFORD BROWN PHONE NO : 972 589 9115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 15-AUG-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
ORIDION MEDICAL 1987 LTD. 510(k) NO: K012394(SPECIAL)
ATTN: SANFORD BROWN PHONE NO : 972 258 99115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 15-AUG-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
ORIDION MEDICAL 1987 LTD. 510(k) NO: K012395(SPECIAL)
ATTN: SANFORD BROWN PHONE NO : 972 258 99115
7 HAMARPE ST. P.O. BOX 45025 SE DECISION MADE: 15-AUG-01
HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: ORTHO DEVELOPMENT ORION-I EMF SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K012129(TRADITIONAL)
ATTN: CAROL FREASIER PHONE NO : 801-553-9991
106 WEST 12200 SOUTH SE DECISION MADE: 22-AUG-01
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K012561(TRADITIONAL)
ATTN: SUSAN WERNER WERNER PHONE NO : 716-453-4469
100 INDIGO CREEK DRIVE SE DECISION MADE: 29-AUG-01
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITR
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K012593(SPECIAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 30-AUG-01
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNULATED PLUS SCREW SYSTEM
ORTHOMATRIX, INC. 510(k) NO: K010738(TRADITIONAL)
ATTN: BEN SHAPPLEY PHONE NO : 901-888-5614
711 CHANEY COVE SE DECISION MADE: 01-AUG-01
COLLIERVILLE, TN 38017 510(k) STATEMENT
DEVICE: ORTELIUS 800
ORTHOSCAN LTD. 510(k) NO: K011827(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
17 AHUZAH ST. SE DECISION MADE: 28-AUG-01
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCS CLARIS SPINAL SCREWS, TYPES V,G,E
ORTHOTEC,LLC 510(k) NO: K011807(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 07-AUG-01
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER A
OSI MEDICAL, INC. 510(k) NO: K012533(TRADITIONAL)
ATTN: JON WERNER PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE SE DECISION MADE: 22-AUG-01
TAMPA, FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED MANDIBULAR FIXATION SYSTEM
OSTEOMEDICS, INC. 510(k) NO: K010118(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 14-AUG-01
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ SYRINGE
OWEN MUMFORD, LTD. 510(k) NO: K011951(TRADITIONAL)
ATTN: ROBERT SHAW PHONE NO : 770-977-2226
1755 A WEST OAK COMMONS COURT SE DECISION MADE: 02-AUG-01
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACEART TX3 CARDIAC EVENT RECORDER
PACEART, INC. 510(k) NO: K012407(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 14-AUG-01
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LC 100 DIODE LASER
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K011747(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 30-AUG-01
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSYST REVEAL
PERSYST DEVELOPMENT CORP. 510(k) NO: K011397(TRADITIONAL)
ATTN: SCOTT B WILSON PHONE NO : 520-708-0705
316 SKYLINE DR. SE DECISION MADE: 03-AUG-01
PRESCOTT, AZ 86303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
PHOTO MEDEX, , INC. 510(k) NO: K011382(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 760-602-3300
2431 IMPALA DR. SE DECISION MADE: 02-AUG-01
CARLSBAD, CA 92008-7227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYTITER SYSTEM
POLYMEDCO, INC. 510(k) NO: K012163(TRADITIONAL)
ATTN: HELLEN LANDICHO PHONE NO : 425-814-1514
510 FURNACE DOCK RD. SE DECISION MADE: 20-AUG-01
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: PRAXSYS RELIA TSH TEST
PRAXSYS BIOSYSTEMS, INC. 510(k) NO: K011527(TRADITIONAL)
ATTN: RICHARD M THAYER PHONE NO : 925-866-2121
12945 ALCOSTA BLVD. SE DECISION MADE: 07-AUG-01
SAN RAMON, CA 94583-1323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ALBERTA LENS SM2, SULFOCON B
PROGRESSIVE OPTICAL RESEARCH LTD. 510(k) NO: K010454(TRADITIONAL)
ATTN: NICK NOVICKY PHONE NO : 403 250 1181
#20, 1410-40TH AVENUE, N.E. SE DECISION MADE: 01-AUG-01
CALGARY, ALBERTA, CANADA T2E 6L1 510(k) STATEMENT
DEVICE: ABN ANEROID SPHYGMOMANOMETER
PT. SUGIH INSTRUMENDO ABADI 510(k) NO: K012444(TRADITIONAL)
ATTN: RICHARD GRAVER PHONE NO : 631-582-7320
933A MOTOR PARKWAY SE DECISION MADE: 16-AUG-01
HAUPPAUGE, NY 11788 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: RADIUS NEXT GENERATION GUIDEWIRE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K011759(TRADITIONAL)
ATTN: MAUREEN FINLAYSON PHONE NO : 978-897-6469
63 GREAT RD. SE DECISION MADE: 23-AUG-01
MAYNARD, MA 01754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX HUMAN ASSSAYED DRUG CONTROL
RANDOX LABORATORIES, LTD. 510(k) NO: K012319(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 24-AUG-01
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX
RANFAC CORP. 510(k) NO: K012224(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-588-4400
30 DOHERTY AVE., P.O. BOX 635 SE DECISION MADE: 22-AUG-01
AVON INDUSTRIAL PARK 510(k) STATEMENT
AVON, MA 02322
DEVICE: BI-PHASIC INFILTRATOR
RELIANCE MEDICAL CORP. 510(k) NO: K012044(TRADITIONAL)
ATTN: ROBERT W NICKS PHONE NO : 970-986-5345
730 INDEPENDENT AVE. SE DECISION MADE: 28-AUG-01
GRAND JUNCTION, CO 81505 510(k) STATEMENT
DEVICE: SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CC
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K002328(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 27-AUG-01
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INS
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K011496(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PARKWAY SE DECISION MADE: 10-AUG-01
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIT AND FISSURE CHEMICAL CURING SEALANT
RITE-DENT MANUFACTURING CORP. 510(k) NO: K011822(TRADITIONAL)
ATTN: CESAR E VELIZ PHONE NO : 305-693-8626
1056 EAST 33RD ST. SE DECISION MADE: 07-AUG-01
HIALEAH, FL 33013-3526 510(k) STATEMENT
DEVICE: MODIFICATION TO ACCU-CHEK INFORM METER
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012210(SPECIAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 09-AUG-01
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATIO
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012286(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 08-AUG-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATI
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012287(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 07-AUG-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ELECSYS FSH II CALSET
ROCHE DIAGNOSTICS CORP. 510(k) NO: K012399(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 24-AUG-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSS EMBRACE PUMP SET
ROSS PRODUCTS 510(k) NO: K011467(TRADITIONAL)
ATTN: DANIEL HAMILTON PHONE NO : 614-624-3743
625 CLEVELAND AVENUE SE DECISION MADE: 10-AUG-01
COLUMBUS, OH 43215-1724 510(k) STATEMENT
DEVICE: THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
RUSCH INTL. 510(k) NO: K011210(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-0204
50 PLANTATION DRIVE SE DECISION MADE: 15-AUG-01
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-PULSE TENS UNIT
SADLER ELECTRONICS 510(k) NO: K010203(TRADITIONAL)
ATTN: C A SADLER PHONE NO : 272 155 84088
3 COETZENBERG ROAD SE DECISION MADE: 28-AUG-01
EDGEMEAD, SOUTH AFRICA 7441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REJUVENIQUE MODEL #RJV10
SALTON, INC. 510(k) NO: K011935(TRADITIONAL)
ATTN: GEORGIA C RAVITZ PHONE NO : 202-857-8939
1050 CONNECTICUT AVE., NW SE DECISION MADE: 08-AUG-01
WASHINGTON, DC 20036-5339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
SEDECAL USA, , INC. 510(k) NO: K012663(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 31-AUG-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HADGEL, 4 GRAM/SYRINGE
SEIKAGAKU CORP. 510(k) NO: K011544(TRADITIONAL)
ATTN: JOHN J SHEA PHONE NO : 252-261-4158
90 POTESKEET TRAIL SE DECISION MADE: 15-AUG-01
KITTY HAWK, NC 27949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
SEIN ELECTRONICS CO., LTD. 510(k) NO: K012054(TRADITIONAL)
ATTN: WON. KY KIM PHONE NO : 82 31 4210389
133-3, PYUNGCHON-DONG SE DECISION MADE: 08-AUG-01
ANYANG-CITY, KYUNGGI-DO, REPUBLIC 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
SEMPERMED USA, INC. 510(k) NO: K011749(TRADITIONAL)
ATTN: KATIE LEVINSON PHONE NO : 727-787-7250
30798 US HWY. 19 NORTH SE DECISION MADE: 22-AUG-01
PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMNO STAR & SERIES SLEEP SYSTEM
SENSORMEDICS CORP. 510(k) NO: K012085(SPECIAL)
ATTN: LINDA MURDOCK PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 02-AUG-01
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN SPACE 3D
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K011447(TRADITIONAL)
ATTN: PRAVEEN NADKARNI PHONE NO : 732-321-4950
186 WOOD AVENUE SOUTH SE DECISION MADE: 03-AUG-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K012461(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 17-AUG-01
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET
SIMS PORTEX LTD. 510(k) NO: K012068(TRADITIONAL)
ATTN: CLAIRE MULLINS PHONE NO : 443 032 60551
HYTHE SE DECISION MADE: 03-AUG-01
HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUCTIVE GEL FOR ULTRASOUND
SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K002832(TRADITIONAL)
ATTN: GEORGE K.C. CHEN PHONE NO : 011 886 225979005
34 CHUNG SHAN NORTH RD., SE DECISION MADE: 06-AUG-01
12TH FL., SEC. 3 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: DIGORA PCT
SOREDEX INSTRUMENTATION CORPORATIO510(k) NO: K012170(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 939 371
NILSIANATU 10-14 SE DECISION MADE: 10-AUG-01
HELSINKI, FINLAND FIN 00510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
SPACELABS BURDICK, INC. 510(k) NO: K011339(TRADITIONAL)
ATTN: JOHN E GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH STREET SE DECISION MADE: 20-AUG-01
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
SPECTRUM BIOTECH, INC. 510(k) NO: K003555(TRADITIONAL)
ATTN: IAN MCDOUGALL PHONE NO : 604 831 9311
821 EAST 17TH STREET SE DECISION MADE: 29-AUG-01
N.VANCOUVER, BRITISH COLUMBIA, CAN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VASCULAR CLOSURE DEVICE
STD MFG., INC. 510(k) NO: K012362(SPECIAL)
ATTN: STEPHEN M PALUMBO PHONE NO : 781-828-4400
1063 TURNPIKE ST. SE DECISION MADE: 23-AUG-01
P.O. BOX 420 510(k) SUMMARY AVAILABLE FROM FDA
STOUGHTON, MA 02072
DEVICE: CROSS-CHECKS DUAL, MODEL CI 125
STERITEC PRODUCTS, INC. 510(k) NO: K010534(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 06-AUG-01
CASTLE ROCK, CO 80104 510(k) STATEMENT
DEVICE: SIMPLICITY EURO QD INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K012330(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 10-AUG-01
LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI DENTAL IMPLANT SYSTEM
STRAUMANN USA 510(k) NO: K012757(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 22-AUG-01
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: STRYKER NAVIGATION SYSTEM-KNEE MODULE
STRYKER CORP. 510(k) NO: K010204(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVENUE SE DECISION MADE: 31-AUG-01
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECH
SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K012066(SPECIAL)
ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018
651 CAMPUS DR. SE DECISION MADE: 01-AUG-01
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECH
SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K012347(SPECIAL)
ATTN: MARCIA R ELLIS PHONE NO : 651-697-4807
651 CAMPUS DR. SE DECISION MADE: 23-AUG-01
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
SULZER SPINE-TECH 510(k) NO: K012305(SPECIAL)
ATTN: JANELL A COLLEY PHONE NO : 952-830-6205
7375 BUSH LAKE RD. SE DECISION MADE: 22-AUG-01
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
SUNMAX ENTERPRISE SHANGHAI CO. LTD510(k) NO: K011717(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 14-AUG-01
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
SUNMAX ENTERPRISE SHANGHAI CO. LTD510(k) NO: K011765(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 302-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 16-AUG-01
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: INTERCEPT-URETHRAL MICROCOIL
SURGI-VISION, INC. 510(k) NO: K011781(TRADITIONAL)
ATTN: NANCY E TAYLOR PHONE NO : 301-527-2000
20 FIRSTFIELD RD. SUITE 200 SE DECISION MADE: 31-AUG-01
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORERESTORE 2
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K011798(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 14-AUG-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POINT 4 FLOWABLE
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K012321(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 27-AUG-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND 2
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K012322(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 30-AUG-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
SYNTHES (USA) 510(k) NO: K011458(ABBREVIATED)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 02-AUG-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES LCP PROXIMAL TIBIA PLATE
SYNTHES (USA) 510(k) NO: K011978(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 09-AUG-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICY
SYVA CO. 510(k) NO: K011878(TRADITIONAL)
ATTN: SUSAN L COLLINS PHONE NO : 408-366-3908
20400 MARIANI AVE. SE DECISION MADE: 13-AUG-01
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL
SYVA CO. 510(k) NO: K012257(SPECIAL)
ATTN: SUSAN L COLLINS PHONE NO : 408-366-3840
20400 MARIANI AVE. SE DECISION MADE: 03-AUG-01
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS CARE, MODEL XL-Y3
TENS CARE LTD. 510(k) NO: K011543(TRADITIONAL)
ATTN: BERNARD JOHN TREMAINE PHONE NO : 44 161 9804310
76, STOCKPORT ROAD SE DECISION MADE: 31-AUG-01
TIMPERLRY, UNITED KINGDOM WA15 7SN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K012209(SPECIAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 15-AUG-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO 30 GAUGE HYPODERMIC NEEDLE
TERUMO MEDICAL CORP. 510(k) NO: K012646(SPECIAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241
125 BLUE BALL ROAD SE DECISION MADE: 27-AUG-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE-X SYSTEM
TG GROUP, INC. 510(k) NO: K012355(TRADITIONAL)
ATTN: WAYNE LEBEAU PHONE NO : 877 557 4888
3505 LAIRD RD. SE DECISION MADE: 09-AUG-01
UNIT 7 510(k) STATEMENT
MISSISSAUGA, ONTARIO, CANADA L5L 5THIRD PARTY REVIEW
DEVICE: ANSPACH EMAX DRILL SYSTEM
THE ANSPACH EFFORT, INC. 510(k) NO: K011444(TRADITIONAL)
ATTN: WILLIAM E ANSPACH PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 08-AUG-01
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
THE BINDING SITE, LTD. 510(k) NO: K012291(TRADITIONAL)
ATTN: JAY GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 20-AUG-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
THE BINDING SITE, LTD. 510(k) NO: K012292(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 31-AUG-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
THE BINDING SITE, LTD. 510(k) NO: K012295(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 20-AUG-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
THE BINDING SITE, LTD. 510(k) NO: K012296(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 31-AUG-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
THE KENDALL COMPANY 510(k) NO: K011941(TRADITIONAL)
ATTN: MICHAEL SPEARS PHONE NO : 508-261-8155
15 HAMPSHIRE ST. SE DECISION MADE: 22-AUG-01
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS SPRAY CATHETER PW-6C-1
THE OLYMPUS OPTICAL CO. 510(k) NO: K012073(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 10-AUG-01
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
THE RX FILES CORP. 510(k) NO: K011571(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 09-AUG-01
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
THERMO-ELECTRIC CO. 510(k) NO: K011768(TRADITIONAL)
ATTN: LAWRENCE E MADSON PHONE NO : 724-695-1890
455 RT. 30 SE DECISION MADE: 03-AUG-01
IMPERIAL, PA 15126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AEQUALIS SHOULDER SYSTEM
TORNIER S.A. 510(k) NO: K012212(SPECIAL)
ATTN: IRENE GOSSET PHONE NO : 00 33 476613500
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 15-AUG-01
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIA-PACK BRCA, ST AIA PACK BRCA
TOSOH MEDICS, INC. 510(k) NO: K010796(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 650-615-4970
347 OYSTER POINT BLVD., SE DECISION MADE: 16-AUG-01
SUITE 201 510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080
DEVICE: HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
TRANSWORLD MOBILITY DISTRIBUTION, 510(k) NO: K011744(ABBREVIATED)
ATTN: JUAN C RIVERA PHONE NO : 941-275-6767
6140 MILD METRO DRIVE SE DECISION MADE: 24-AUG-01
SUITE #6 510(k) STATEMENT
FORT MYERS, FL 33912
DEVICE: HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
TRANSWORLD MOBILITY DISTRIBUTION, 510(k) NO: K011745(ABBREVIATED)
ATTN: JUAN C RIVERA PHONE NO : 941-458-9290
6140 MILD METRO DRIVE SE DECISION MADE: 30-AUG-01
SUITE #6 510(k) STATEMENT
FORT MYERS, FL 33912
DEVICE: SENSITITIRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K011803(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 15-AUG-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K012151(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 29-AUG-01
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
TREX ENTERPRISES CORP. 510(k) NO: K012379(TRADITIONAL)
ATTN: PETER J MARTIN PHONE NO : 858-875-2616
10455 PACIFIC CENTER CT. SE DECISION MADE: 16-AUG-01
SAN DIEGO, CA 92121-4339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAO EMBRYO TRANSFER CATHETER SYSTEM
TTJ BIOMEDICAL, LLC. 510(k) NO: K012220(TRADITIONAL)
ATTN: RICHARD JORTBERG PHONE NO : 303-444-5026
2885 AURORA AVENUE, SUITE 15 SE DECISION MADE: 27-AUG-01
BOULDER, CO 80303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACELL ABSORBENT STICK
ULTRACELL MEDICAL TECHNOLOGIES, IN510(k) NO: K012196(TRADITIONAL)
ATTN: COLLEEN MARTIN PHONE NO : 860-599-4883
183 PROVIDENCE, SE DECISION MADE: 24-AUG-01
NEW LONDON TNPK 510(k) STATEMENT
NORTH STONINGTON, CT 06359
DEVICE: SPIRAL RADIUS 90-D SST SYSTEM
UNITED STATES SURGICAL, A DIVISION510(k) NO: K012273(SPECIAL)
ATTN: JENNIFER SCHUCK PHONE NO : 203-845-1552
150 GLOVER AVE. SE DECISION MADE: 15-AUG-01
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NURSE'S ASSISTANT O.R. CONTROL SYSTEM
VAL MED CORP. 510(k) NO: K010754(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN, ESQ. PHONE NO : 202-637-5839
555 THIRTEENTH STREET N.W. SE DECISION MADE: 15-AUG-01
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
VYSIS 510(k) NO: K011031(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 630-271-7040
3100 WOODCREEK DR. SE DECISION MADE: 03-AUG-01
DOWNERS GROVE, IL 60515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WH ACCU TEST PREGNANCY TEST
W.H.P.M., INC. 510(k) NO: K012284(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 28-AUG-01
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO IMMUNOASSAY CALIBRATOR SET
WAKO CHEMICALS, USA, INC. 510(k) NO: K010332(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 01-AUG-01
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VHS PEDIATRIC HIP SCREW SYSTEM
WALTER ABENDSCHEIN, M.D. 510(k) NO: K011603(TRADITIONAL)
ATTN: WALTER ABENDSCHEIN PHONE NO : 301-656-4317
5530 WISCONSIN AVENUE SE DECISION MADE: 15-AUG-01
SUITE 705 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: ADD-ON CONDYLE
WALTER LORENZ SURGICAL, INC. 510(k) NO: K002790(TRADITIONAL)
ATTN: TREVOR BYRD PHONE NO : 904-741-4400
11520 TRADEPORT DRIVE SE DECISION MADE: 06-AUG-01
JACKSONVILLE, FL 32218-2480 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WECK CARDIAC PACING WIRES
WECK CLOSURE SYSTEMS 510(k) NO: K011660(TRADITIONAL)
ATTN: BRIAN YOUNG PHONE NO : 919-361-4041
ONE WECK DR. SE DECISION MADE: 21-AUG-01
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 2
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K012451(SPECIAL)
ATTN: DONALD M ABBEY PHONE NO : 800-289-2500
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 20-AUG-01
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
WELCH ALLYN, INC. 510(k) NO: K012455(ABBREVIATED)
ATTN: DAVID A YOUNG PHONE NO : 828-684-4895
95 OLD SHOALS RD. SE DECISION MADE: 17-AUG-01
ARDEN, NC 28704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGINE H.E.
WIELAND EDELMETALLE GMBH & CO. 510(k) NO: K012156(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 16-AUG-01
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K012048(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 60 3 87061486
LOT 1, JALAN 3, SE DECISION MADE: 16-AUG-01
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LAB
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K012135(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 870 61486
LOT 1, JALAN 3, SE DECISION MADE: 01-AUG-01
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
XIROS PLC 510(k) NO: K002172(TRADITIONAL)
ATTN: JIM ROWLAND PHONE NO : 441 132 446946
28-30 BLENHEIM TERRACE SE DECISION MADE: 28-AUG-01
LEEDS, UNITED KINGDOM LS2 9HD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
510(k) NO: K012280(SPECIAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
SE DECISION MADE: 17-AUG-01
510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 340
TOTAL WITH SUMMARIES 260
TOTAL WITH STATEMENTS 80
Updated 9/7/2001
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