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510(k)s Final Decisions Rendered for December 2000 |
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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-DEC-2000 THROUGH 31-DEC-2000
DEVICE: AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
AARON MEDICAL INDUSTRIES 510(k) NO: K001955(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 22-DEC-00
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA 60C+ HEMATOLOGY ANALYZER
ABX DIAGNOSTICS, INC. 510(k) NO: K003677(SPECIAL)
ATTN: BRUCE H DAVIS PHONE NO : 207-842-7914
34 BUNSEN DR. SE DECISION MADE: 26-DEC-00
IRVINE, CA 92618-4210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
ACUSON CORPORATION 510(k) NO: K002807(TRADITIONAL)
ATTN: CHALON GREEN PHONE NO : 650-969-9112
1220 CHARLESTON RD. SE DECISION MADE: 01-DEC-00
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC INGESTASCAN
ADAMS ELECTRONICS, INC. 510(k) NO: K003305(TRADITIONAL)
ATTN: ROBERT E ADAMS PHONE NO : 580-233-6886
110 A SUNSET PLAZA SE DECISION MADE: 22-DEC-00
PMB 311 510(k) STATEMENT
ENID, OK 73703
DEVICE: FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
ADRI/TECHNAM 510(k) NO: K003134(TRADITIONAL)
ATTN: GEORGE H SCHERR PHONE NO : 708-747-3717
P.O. BOX 134 SE DECISION MADE: 22-DEC-00
PARK FOREST, IL 60466 510(k) STATEMENT
DEVICE: AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS
AGILENT TECHNOLOGIES DEUTSCHLAND G510(k) NO: K003038(TRADITIONAL)
ATTN: EGON PFEIL PHONE NO : 031-464-7223
HERRENBERGER ST. 130 SE DECISION MADE: 15-DEC-00
D 71034 BOEBLINGEN 510(k) SUMMARY AVAILABLE FROM FDA
BOEBLINGEN,, GERMANY
DEVICE: HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K003565(SPECIAL)
ATTN: GRETCHEN SOLBERG PHONE NO : 206-664-5000
2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 20-DEC-00
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
AGILENT TECHNOLOGIES, INC. 510(k) NO: K003621(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 20-DEC-00
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K003622(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 18-DEC-00
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTOR
AIR TECHNIQUES, INC. 510(k) NO: K002122(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 21-DEC-00
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: MEDIPRIME
ALGOTEC SYSTEMS, LTD. 510(k) NO: K002894(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 299 32768
P.O. BOX 6718 SE DECISION MADE: 05-DEC-00
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SSD-4000
ALOKA CO., LTD. 510(k) NO: K003739(ABBREVIATED)
ATTN: CHRISTOPER BOHL PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 27-DEC-00
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIW WATER SYSTEM FOR HEMODIALYSIS
AMERICAN INDUSTRIAL WATER 510(k) NO: K001282(TRADITIONAL)
ATTN: JOE GREENING PHONE NO : 316-733-5798
327 S. HYDRAULIC SE DECISION MADE: 15-DEC-00
WICHITA, KS 67211 510(k) STATEMENT
DEVICE: ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K003769(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, SE SE DECISION MADE: 22-DEC-00
MASSILLON, OH 44646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWIT
ARTHROCARE CORP. 510(k) NO: K003624(SPECIAL)
ATTN: BETTY M JOHNSON PHONE NO : 408-735-6426
595 NORTH PASTORIA AVE. SE DECISION MADE: 20-DEC-00
SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHACOFRAGMENTATION SYSTEM MEGATRON
ASCLEPION-MEDITEC AG 510(k) NO: K002031(TRADITIONAL)
ATTN: DIRK COLDITZ PHONE NO : 493 641 653453
2525 MC GAW AVENUE SE DECISION MADE: 27-DEC-00
IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVITA TSO/TS1 INFRARED EAR THERMOMETER
AVITA INTERNATIONAL CORP. 510(k) NO: K002182(TRADITIONAL)
ATTN: ALLEN REICH PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142 SE DECISION MADE: 29-DEC-00
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSOMAT P
B. BRAUN MEDICAL, INC. 510(k) NO: K003029(TRADITIONAL)
ATTN: GARY A GULTAS PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150 SE DECISION MADE: 04-DEC-00
CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SY
BAXTER HEALTHCARE CORP. 510(k) NO: K003245(SPECIAL)
ATTN: LINDA COLEMAN PHONE NO : 847-270-4781
RT. 120 & WILSON RD. SE DECISION MADE: 04-DEC-00
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
BAXTER HEALTHCARE CORP. 510(k) NO: K003616(SPECIAL)
ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825
RT. 120 & WILSON RD. SE DECISION MADE: 12-DEC-00
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMO-AIDE DISPENSING PIN
BAXTER HEALTHCARE CORP. 510(k) NO: K003730(TRADITIONAL)
ATTN: JUDY KANNENBERG PHONE NO : 847-270-4644
RT. 120 & WILSON RD. SE DECISION MADE: 20-DEC-00
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER RAPIDPOINT 400 SYSTEM
BAYER CORP. 510(k) NO: K002738(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 19-DEC-00
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
BAYER DIAGNOSTICS CORPORATION 510(k) NO: K003291(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH STREET SE DECISION MADE: 05-DEC-00
MEDFIELD, MA 02052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS AMMONIA REAGENT
BECKMAN COULTER, INC. 510(k) NO: K003196(TRADITIONAL)
ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777
200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 22-DEC-00
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-LOGIC SLEEPSCAN NETLINK
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K003681(SPECIAL)
ATTN: NORMAN E BRUNNER PHONE NO : 800-323-8326
ONE BIO-LOGIC PLAZA SE DECISION MADE: 21-DEC-00
MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIANT II TOTAL GHB
BIO-RAD LABORATORIES 510(k) NO: K003280(TRADITIONAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR. SE DECISION MADE: 19-DEC-00
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPELAND RESURFACING HEADS
BIOMET, INC. 510(k) NO: K003044(TRADITIONAL)
ATTN: SARA A BAILEY PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 13-DEC-00
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOMET EXTERNAL WRIST PLATE
BIOMET, INC. 510(k) NO: K003240(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 219-372-1761
56 EAST BELL DRIVE SE DECISION MADE: 29-DEC-00
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2A 32MM TAPER SYSTEM
BIOMET, INC. 510(k) NO: K003363(SPECIAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644
56 EAST BELL DRIVE SE DECISION MADE: 15-DEC-00
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTEQ I.V. (INTRAVENOUS) SET
BIOTEQUE CORP. 510(k) NO: K002449(TRADITIONAL)
ATTN: JENNIFER CHEN PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142 SE DECISION MADE: 22-DEC-00
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRD TBIRD LEGACY VENTILATOR
BIRD PRODUCTS CORP. 510(k) NO: K003770(SPECIAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 15-DEC-00
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY S
BOSTON SCIENTIFIC CORP. 510(k) NO: K003100(TRADITIONAL)
ATTN: RON BENNETT PHONE NO : 763-694-5642
5905 NATHAN LANE SE DECISION MADE: 20-DEC-00
MINNEAPOLIS, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRECLIP TORQUER
BOSTON SCIENTIFIC CORPORATION NORT510(k) NO: K003398(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-556-1667
17425 N.E. UNION HILL ROAD SE DECISION MADE: 01-DEC-00
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
BREG, INC. 510(k) NO: K003611(SPECIAL)
ATTN: KATHLEEN BARBER PHONE NO : 760-599-5719
2611 COMMERCE WAY SE DECISION MADE: 13-DEC-00
VISTA, CA 92083 510(k) STATEMENT
DEVICE: BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOL
C.R. BARD, INC. 510(k) NO: K002868(ABBREVIATED)
ATTN: ANGELA L BUNN PHONE NO : 770-784-6774
8195 INDUSTRIAL BLVD. SE DECISION MADE: 08-DEC-00
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTOUCH
CARDIONICS, INC. 510(k) NO: K002197(ABBREVIATED)
ATTN: JEFF MORGAN PHONE NO : 253-535-9369
13723 DANA LANE EAST SE DECISION MADE: 27-DEC-00
PUYALLUP, WA 98373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTIST
CASTELLINI S.P.A. 510(k) NO: K000834(TRADITIONAL)
ATTN: GIULIANO LANZARINI PHONE NO : 051 700 877
VIA SALICETO 22 SE DECISION MADE: 14-DEC-00
CASTEL MAGGIORE, BOLOGNA, ITALY 40510(k) STATEMENT
DEVICE: PLACEMENT-PLUS
CATHETER INNOVATIONS, INC. 510(k) NO: K003642(SPECIAL)
ATTN: ROGER L RICHINS PHONE NO : 801-954-8444
3598 WEST 1820 SOUTH SE DECISION MADE: 20-DEC-00
SALT LAKE CITY, UT 84104-4859 510(k) STATEMENT
DEVICE: MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
CHAD THERAPEUTICS, INC. 510(k) NO: K003455(SPECIAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883
21622 PLUMMER ST. SE DECISION MADE: 06-DEC-00
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAIL
CIBA VISION CORP. 510(k) NO: K003071(SPECIAL)
ATTN: TERRINA WILDER PHONE NO : 678-415-3809
11460 JOHNS CREEK PKWY. SE DECISION MADE: 13-DEC-00
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
CODMAN & SHURTLEFF, INC. 510(k) NO: K002798(TRADITIONAL)
ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404
325 PARAMOUNT DRIVE SE DECISION MADE: 06-DEC-00
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAKIM PROGRAMMER AND TRANSMITTER
CODMAN & SHURTLEFF, INC. 510(k) NO: K003564(SPECIAL)
ATTN: LAURA O'GRADY PHONE NO : 508-828-3164
325 PARAMOUNT DR. SE DECISION MADE: 20-DEC-00
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVIC MUSCLE THERAPY
COLONIAL MEDICAL SUPPLY 510(k) NO: K002830(TRADITIONAL)
ATTN: PATRICIA LEIGH, R.N. PHONE NO : 800-634-9334
1350 E. FLAMINGO RD. # 343 SE DECISION MADE: 27-DEC-00
LAS VEGAS, NV 89119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
COM-MED INTERNATIONAL, INC. 510(k) NO: K002691(TRADITIONAL)
ATTN: MICHELE VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 08-DEC-00
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUMEDICS SIESTA SYSTEM
COMPUMEDICS SLEEP PTY LTD. 510(k) NO: K003175(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 612-574-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 27-DEC-00
MINNEAPOLIS,, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFORMANCE CHEMISTRY CONTROL C3
CONSOLIDATED TECHNOLOGY 510(k) NO: K003716(TRADITIONAL)
ATTN: RUSTY SEWELL PHONE NO : 512-445-5100
4401 FREIDRICH LANE BLDG 1 SE DECISION MADE: 20-DEC-00
SUITE 100 510(k) STATEMENT
AUSTIN, TX 78744-1832
DEVICE: SURGISIS PERIPHERAL VASCULAR PATCH
COOK BIOTECH, INC. 510(k) NO: K001785(TRADITIONAL)
ATTN: NEAL E FEARNOT PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 27-DEC-00
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH "VARIA-II" ND:YAG LASER SYSTEM
COOLTOUCH CORPORATION 510(k) NO: K003781(SPECIAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900
9085 FOOTHILLS BOULEVARD SE DECISION MADE: 20-DEC-00
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVENT IMPLANT SYSTEM
CORE-VENT CORP. 510(k) NO: K002614(TRADITIONAL)
ATTN: WILL FISHER PHONE NO : 702-253-1344
4630 SOUTH ARVILLE, SUITE D SE DECISION MADE: 08-DEC-00
LAS VEGAS, NV 89103 510(k) STATEMENT
DEVICE: METALYZER, MODEL 2; METALYZER, MODEL 3
CORTEX BIOPHYSIK GMBH 510(k) NO: K993641(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-287-2382
962 ALLEGRO LANE SE DECISION MADE: 14-DEC-00
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOSURGICAL UNIT AND ACCESSORIES
CRYOGEN, INC. 510(k) NO: K003050(TRADITIONAL)
ATTN: CHERYL L SHEA PHONE NO : 858-450-7419
11065 SORRENTO VALLEY CT. SE DECISION MADE: 26-DEC-00
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECAT PET SCANNER
CTI PET SYSTEMS, INC. 510(k) NO: K003241(TRADITIONAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 13-DEC-00
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION
CYBERCARE TECHNOLOGIES, INC. 510(k) NO: K002984(TRADITIONAL)
ATTN: J. TERRY DRURY PHONE NO : 770-352-9540
7840 ROSWELL RD., BLDG. 300 SE DECISION MADE: 18-DEC-00
SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30350-4889
DEVICE: EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
CYBERCARE TECHNOLOGIES, INC. 510(k) NO: K003257(TRADITIONAL)
ATTN: GORDON J PETERS PHONE NO : 770-352-9540
7840 ROSWELL RD., BLDG. 300 SE DECISION MADE: 22-DEC-00
SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30350-4889
DEVICE: URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. D
DADE BEHRING, INC. 510(k) NO: K003209(TRADITIONAL)
ATTN: CATHY P CRAFT PHONE NO : 302-631-6280
P.O. BOX 6101 SE DECISION MADE: 05-DEC-00
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. A
DATASCOPE CORP. 510(k) NO: K003598(SPECIAL)
ATTN: JOANN WOLF PHONE NO : 973-244-6123
15 LAW DR. SE DECISION MADE: 21-DEC-00
FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5
DAVOL, INC. 510(k) NO: K003790(TRADITIONAL)
ATTN: LUCINDA L FOX PHONE NO : 401-463-7000
SUBSIDIARY OF C.R. BARD SE DECISION MADE: 22-DEC-00
100 SOCKANOSSETT CROSSROAD 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920
DEVICE: NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP,
DAVOL, INC., SUB. C.R. BARD, INC. 510(k) NO: K003674(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 08-DEC-00
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLBLU CURING LIGHT
DENTAL SYSTEMS.COM, INC. 510(k) NO: K002925(TRADITIONAL)
ATTN: SHINOBU DOI PHONE NO :
1187 TADSWORTH TRAIL SE DECISION MADE: 20-DEC-00
HEATHROW, FL 32746 510(k) STATEMENT
DEVICE: SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
DEPUY ACROMED 510(k) NO: K002733(TRADITIONAL)
ATTN: FRANK MASS PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 15-DEC-00
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY C-STEM SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003421(SPECIAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDICS DR. SE DECISION MADE: 01-DEC-00
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
VARSAW, IN 46581-0988
DEVICE: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001738(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
P.O. BOX 988 SE DECISION MADE: 27-DEC-00
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003523(SPECIAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903
P.O. BOX 988 SE DECISION MADE: 13-DEC-00
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE AIM TTC FUSION NAIL
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003797(SPECIAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 15-DEC-00
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: ACAPELLA
DHD HEALTHCARE CORP. 510(k) NO: K002768(TRADITIONAL)
ATTN: LAWRENCE WEINSTEIN PHONE NO : 315-363-2330
ONE MADISON ST. SE DECISION MADE: 05-DEC-00
WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CR
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K003372(TRADITIONAL)
ATTN: EDWARDS M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 26-DEC-00
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
DIAGNOSTIC SYSTEMS LABORATORIES, I510(k) NO: K002128(TRADITIONAL)
ATTN: MICHAEL (RUSTY) NICAR PHONE NO : 281-332-9678
445 MEDICAL CENTER BLVD. SE DECISION MADE: 05-DEC-00
WEBSTER, TX 77598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION INTERLOCKING NAIL (FIXION IL NAIL)
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K002783(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600
COLUMBIA SQUARE SE DECISION MADE: 05-DEC-00
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: FIXION INTRAMEDULLARY NAILING SYSTEM ("FIXION IM NAIL")
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K003212(TRADITIONAL)
ATTN: JOHNATHAN S KAHAN PHONE NO : 202-637-5794
COLUMBIA SQUARE SE DECISION MADE: 28-DEC-00
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM ("FIXION IM
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K003215(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
COLUMBIA SQUARE SE DECISION MADE: 27-DEC-00
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: CALEO
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K003067(ABBREVIATED)
ATTN: JIM BRENNAN PHONE NO : 215-721-5400
3136 QUARRY ROAD SE DECISION MADE: 13-DEC-00
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
ELECTRIC MOBILITY CORP. 510(k) NO: K002616(SPECIAL)
ATTN: WALTER F ZARZYOKI PHONE NO : 856-468-1000
1 MOBILITY PLAZA SE DECISION MADE: 11-DEC-00
SEWELL, NJ 08080 510(k) STATEMENT
DEVICE: QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
ELGEMS, LTD. 510(k) NO: K003264(TRADITIONAL)
ATTN: DAN LAOR PHONE NO : 972 485 63666
10 HAYOZMA ST., P.O. BOX 170 SE DECISION MADE: 21-DEC-00
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETABULAR PLATES
ENCORE ORTHOPEDICS, INC. 510(k) NO: K002941(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 04-DEC-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
EP TECHNOLOGIES, INC. 510(k) NO: K003452(SPECIAL)
ATTN: CHRISTINA ROWE PHONE NO : 408-895-3526
2710 ORCHARD PKWY. SE DECISION MADE: 07-DEC-00
SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNOESCREEN PRO, ALPHA SCREEN PRO
ERICH JAEGER, INC. 510(k) NO: K000396(TRADITIONAL)
ATTN: LARRY MURDOCK PHONE NO : 714-283-2228
22705 SAVI RANCH PARKWAY SE DECISION MADE: 27-DEC-00
YORBA LINDA, CA 92887 510(k) STATEMENT
DEVICE: MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
ESCALON MEDICAL CORP. 510(k) NO: K002920(TRADITIONAL)
ATTN: RONALD HUENEKE PHONE NO : 800-433-8197
2440 SOUTH 179TH STREET SE DECISION MADE: 18-DEC-00
NEW BERLIN, WI 53146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RYTHMIC AND RYTHMIC UV
ESSILOR INTL. 510(k) NO: K003170(TRADITIONAL)
ATTN: CHRISTINE MOENCH PHONE NO : 148 958 1182
CLIFTON HOUSE BRUNEL WAY SE DECISION MADE: 15-DEC-00
SEGENSWORTH EAST, FAREHAM 510(k) SUMMARY AVAILABLE FROM FDA
HAMPSHIRE, UNITED KINGDOM PO15 5TX
DEVICE: ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03,
ETHICON ENDO-SURGERY, INC. 510(k) NO: K002906(TRADITIONAL)
ATTN: RUTH ANN WOOD PHONE NO : 513-337-3468
4545 CREEK RD. SE DECISION MADE: 15-DEC-00
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARGLIDE PRECISION BIPOLAR DEVICE
ETHICON, INC. 510(k) NO: K003587(TRADITIONAL)
ATTN: GREGORY R JONES PHONE NO : 908-218-2481
P.O. BOX 151 SE DECISION MADE: 04-DEC-00
SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
FLUIDSENSE CORP. 510(k) NO: K003582(SPECIAL)
ATTN: THOMAS CONNELLY PHONE NO : 978-499-3900
260 MERRIMAC ST. SE DECISION MADE: 05-DEC-00
NEWBURYPORT, MA 01950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
FOTONA D.D. 510(k) NO: K002884(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 151 11215
STEGNE 7, SE DECISION MADE: 04-DEC-00
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K002761(TRADITIONAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE. SE DECISION MADE: 04-DEC-00
TWO LEDGEMONT CENTER 510(k) SUMMARY AVAILABLE FROM FDA
LEXINGTON, MA 02420-9192
DEVICE: FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS,
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K003445(SPECIAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVENUE SE DECISION MADE: 01-DEC-00
LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE ADVANCE NXI PET SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K003849(SPECIAL)
ATTN: D DUERSTELER PHONE NO : 262-785-8219
P.O. BOX 414 SE DECISION MADE: 22-DEC-00
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE O'NEIL STERILE FIELD URINARY CATHETER KIT
GO MEDICAL INDUSTRIES PTY. LTD. 510(k) NO: K002803(TRADITIONAL)
ATTN: GEORGE O'NEIL PHONE NO : 61 8 93881991
200 CHURCHILL AVE. SE DECISION MADE: 27-DEC-00
SUBIACO, PERTH, AUSTRALIA 6008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
GRAMS AMERICAN SUTURE, INC. 510(k) NO: K002999(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO PHONE NO : 262-375-0227
2225 DAKOTA DRIVE SE DECISION MADE: 18-DEC-00
GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAMS NYLON NONABSORBABLE SUTURE
GRAMS AMERICAN SUTURE, INC. 510(k) NO: K003000(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO PHONE NO : 262-375-0227
2225 DAKOTA DRIVE SE DECISION MADE: 18-DEC-00
GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAMS SILK NONABSORBABLE SUTURE
GRAMS AMERICAN SUTURE, INC. 510(k) NO: K003001(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO PHONE NO : 262-375-0227
2225 DAKOTA DRIVE SE DECISION MADE: 15-DEC-00
GRAFTON, WI 53024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
GREER LABORATORIES, INC. 510(k) NO: K003195(TRADITIONAL)
ATTN: GERALD FRIESEN PHONE NO : 828-754-5327
639 NUWAY CIRCLE, N.E. SE DECISION MADE: 13-DEC-00
P.O. BOX 800 510(k) SUMMARY AVAILABLE FROM FDA
LENOIR, NC 28645-0800
DEVICE: PLASMAKINETIC ENDOUROLOGY SYSTEM
GYRUS MEDICAL LTD. 510(k) NO: K003569(SPECIAL)
ATTN: DAVID KAY PHONE NO : 440 292 0776300
FORTRAN RD., ST. MELLONS SE DECISION MADE: 19-DEC-00
CARDIFF, UNITED KINGDOM CF3 0LT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISA BIOPSY NEEDLE
H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K002944(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO :
131 HIGHWAY DRIVE SE DECISION MADE: 19-DEC-00
SOUTH GLASTONBURY, CT 06073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILENT BIOPSY NEEDLE
H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K002946(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO :
131 HIGHWAY DRIVE SE DECISION MADE: 19-DEC-00
SOUTH GLASTONBURY, CT 06073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMOL ASPIRATION BIOPSY NEEDLE
H.S. HOSPITAL SERVICE S.R.L. 510(k) NO: K002947(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO :
131 HIGHWAY DRIVE SE DECISION MADE: 19-DEC-00
SOUTH GLASTONBURY, CT 06073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
HAND INNOVATIONS, INC. 510(k) NO: K002775(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 05-DEC-00
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANGER CRANIAL BAND
HANGER ORTHOPEDIC GROUP, INC. 510(k) NO: K001669(TRADITIONAL)
ATTN: JOSEPH MCTERNAN PHONE NO : 301-280-4528
2 BETHESDA METRO CENTER SE DECISION MADE: 08-DEC-00
BETHESDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDY DISK, CEFPODOXINE, 10MCG
HARDY DIAGNOSTICS 510(k) NO: K003532(TRADITIONAL)
ATTN: MELISSA M TRAYLOR, RAC PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 13-DEC-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: TRIDENT ALL POLY CUP
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001956(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 11-DEC-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K002923(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 18-DEC-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN TIBIAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K003018(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 15-DEC-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
HOWMEDICA OSTEONICS CORP. 510(k) NO: K003211(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 15-DEC-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS ROD FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K003490(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 08-DEC-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
HYPERTEC, INC. 510(k) NO: K002794(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 06-DEC-00
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
HYPERTEC, INC. 510(k) NO: K002795(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 06-DEC-00
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
ICS MEDICAL CORP. 510(k) NO: K002985(TRADITIONAL)
ATTN: DELMAR F BLOEM PHONE NO : 800-289-2150
125 COMMERCE DR. SE DECISION MADE: 13-DEC-00
SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
IGC-MEDICAL ADVANCES, INC. 510(k) NO: K003366(TRADITIONAL)
ATTN: MICHAEL J LEIGH PHONE NO : 414-258-3808
10437 INNOVATION DRIVE SE DECISION MADE: 22-DEC-00
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150
IMATRON, INC. 510(k) NO: K001550(TRADITIONAL)
ATTN: J. A CODUTO PHONE NO : 503-638-5500
389 OYSTER POINT BLVD. SE DECISION MADE: 11-DEC-00
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFX ANGLED RODS
IMMEDICA, INC. 510(k) NO: K003205(TRADITIONAL)
ATTN: ROY BOGERT PHONE NO : 973-635-9040
100 PASSAIC AVE. SE DECISION MADE: 15-DEC-00
CHATHAM, NJ 07928-2848 510(k) STATEMENT
DEVICE: CRIT-LINE MONITOR III (CLM III)
IN-LINE DIAGNOSTICS CORP. 510(k) NO: K001763(TRADITIONAL)
ATTN: MATTHEW L HAYNIE PHONE NO : 801-451-9000
695 NORTH, 900 WEST SE DECISION MADE: 20-DEC-00
KAYSVILLE, UT 84037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEPSTRIP DISPOSABLE APNEA SCREENER
INFLUENT LTD. 510(k) NO: K002135(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 06-DEC-00
WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
INNOLATEX SDN. BHD 510(k) NO: K002393(ABBREVIATED)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO 16, JALAN BULAN U5/5 SE DECISION MADE: 19-DEC-00
BANDAR PINGGIRAN SUBANG, 510(k) STATEMENT
SHAH ALAM,SELANGOR DARUL EHSAN, MALAYSIA
DEVICE: NEURO II
INNOVATIVE MAGNETIC RESONANCE IMAG510(k) NO: K002964(TRADITIONAL)
ATTN: JOEL S FADEN PHONE NO : 301-881-9239
11605 HITCHING POST LANE SE DECISION MADE: 19-DEC-00
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-XX OXYGEN SENSORS
INTERNATIONAL BUSINESS STRATEGIES 510(k) NO: K002384(ABBREVIATED)
ATTN: WILLIAM ROETTGER PHONE NO : 843-224-0553
1667A MARSH HABOR LANE SE DECISION MADE: 15-DEC-00
MOUNT PLEASANT, SC 29464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INTRALASE 600C LASER KERATOME
INTRALASE CORPORATION 510(k) NO: K001211(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
18732 SAGINAW SE DECISION MADE: 04-DEC-00
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DE
INTRATHERAPEUTICS, INC. 510(k) NO: K003040(TRADITIONAL)
ATTN: MARIA E BRITTLE PHONE NO : 651-697-2018
651 CAMPUS DR. SE DECISION MADE: 28-DEC-00
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
INTRATHERAPEUTICS, INC. 510(k) NO: K003450(SPECIAL)
ATTN: AMY PETERSON PHONE NO : 612-697-2076
651 CAMPUS DR. SE DECISION MADE: 07-DEC-00
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K003448(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 07-DEC-00
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
ISOTOPES AND METALS LTD. 510(k) NO: K000081(TRADITIONAL)
ATTN: GIOVANNI LEO PHONE NO : 41 227 861106
29, CH DE GRANGE CANAL SE DECISION MADE: 19-DEC-00
GENEVA, SWITZERLAND CH-1208 510(k) STATEMENT
DEVICE: FERMIT PLUS
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003374(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 800-533-6825
175 PINEVIEW DR. SE DECISION MADE: 04-DEC-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: FERMIT N PLUS
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003377(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 800-533-6825
175 PINEVIEW DR. SE DECISION MADE: 04-DEC-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: DW 273 #1
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003632(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 20-DEC-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: DW 277 #4
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003633(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 20-DEC-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: DW 272 #1
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003634(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 21-DEC-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: DW 276 #3
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003635(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 22-DEC-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: CREATININE
JAS DIAGNOSTIC, INC. 510(k) NO: K003247(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 14-DEC-00
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: ALBUMIN
JAS DIAGNOSTIC, INC. 510(k) NO: K003327(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 05-DEC-00
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: GOLD CORE HF PRE SOLDER
JENERIC/PENTRON, INC. 510(k) NO: K002815(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 19-DEC-00
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: GOLD CORE POST SOLDER
JENERIC/PENTRON, INC. 510(k) NO: K002854(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 20-DEC-00
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: JEWEL CAST III
JENERIC/PENTRON, INC. 510(k) NO: K003037(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 05-DEC-00
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: JEWEL CAST II
JENERIC/PENTRON, INC. 510(k) NO: K003039(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 05-DEC-00
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
KATECHO, INC. 510(k) NO: K003228(TRADITIONAL)
ATTN: WARREN R WALTERS PHONE NO : 515-244-1212
2500 BELL AVE. SE DECISION MADE: 14-DEC-00
DES MOINES, IA 50321 510(k) STATEMENT
DEVICE: OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-3242
LABOTECT LABOR-TECHNIK GOTTINGEN 510(k) NO: K003056(TRADITIONAL)
ATTN: ANGELIKA ALBRECHT PHONE NO : 055 150 5010
WILLI-EICHLER-STR. 25 SE DECISION MADE: 13-DEC-00
GOTTINGEN, GERMANY D-37079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
LAKE REGION MFG., INC. 510(k) NO: K003483(SPECIAL)
ATTN: JIM KLOSTERMAN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 06-DEC-00
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATI
LASERSCOPE 510(k) NO: K003147(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 408-943-0636
3052 ORCHARD DR. SE DECISION MADE: 15-DEC-00
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (
LES LABORATOIRES BLANCHARD 510(k) NO: K003161(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 N. WABASH, SUITE 1200 SE DECISION MADE: 15-DEC-00
CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATURN BLOOD GLUCOSE MONITORING TEST STRIP
LIFESCAN, INC. 510(k) NO: K001441(TRADITIONAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-263-9789
1000 GIBRALTAR DR. SE DECISION MADE: 18-DEC-00
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND S
MALGAM ENT. INC. 510(k) NO: K002569(TRADITIONAL)
ATTN: MICHAEL L GAMBLE PHONE NO : 800-282-5652
2 CLARENCE PL., #12 SE DECISION MADE: 12-DEC-00
SAN FRANCISCO, CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RDH BANDAGE
MARINE POLYMER TECHNOLOGIES, INC. 510(k) NO: K002550(TRADITIONAL)
ATTN: SERGIO FINKIELSZTEIN PHONE NO : 978-777-2950
107 WATER ST. SE DECISION MADE: 20-DEC-00
DANVERS, MA 01923 510(k) STATEMENT
DEVICE: VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER
MED-PRO TECHNOLOGIES, INC. 510(k) NO: K000714(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 21-DEC-00
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP BIO-CATH CATHETER LINE
MEDCOMP 510(k) NO: K003110(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DRIVE SE DECISION MADE: 01-DEC-00
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
MEDICAL ADVANCES, INC. 510(k) NO: K003144(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 13-DEC-00
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
MEDICAL ADVANCES, INC. 510(k) NO: K003685(TRADITIONAL)
ATTN: MICHAEL LEIGH PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 22-DEC-00
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
MEDICAL DESIGNS L.L.C. 510(k) NO: K002970(TRADITIONAL)
ATTN: PAUL JOHN AXT PHONE NO : 605-376-6008
213 SUNSET DRIVE SE DECISION MADE: 12-DEC-00
BRANDON, SD 57005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEDEFIBRILLATOR
MEDICAL RESEARCH LABORATORIES, INC510(k) NO: K002232(TRADITIONAL)
ATTN: JOEL ORLINSKY PHONE NO : 847-520-0300
1000 ASBURY DRIVE SE DECISION MADE: 06-DEC-00
NO.17 510(k) STATEMENT
BUFFALO GROVE, IL 60089
DEVICE: VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K003687(SPECIAL)
ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 22-DEC-00
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K000641(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 22-DEC-00
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION TREATMENT GUIDANCE PLATFORM
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K003201(TRADITIONAL)
ATTN: RONALD K SMITH PHONE NO : 720-890-3200
826 COAL CREEK CIRCLE SE DECISION MADE: 12-DEC-00
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPS 3000 SYSTEM
MEDTRONIC XOMED 510(k) NO: K002224(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. N. SE DECISION MADE: 04-DEC-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEROGEL CONTROL GEL ENT SURGICAL DRESSING
MEDTRONIC XOMED 510(k) NO: K002972(TRADITIONAL)
ATTN: DIANA PRESTON PHONE NO : 904-332-8959
6743 SOUTHPOINT DR. N. SE DECISION MADE: 15-DEC-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIV
MEDTRONIC, INC. 510(k) NO: K003724(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 763-391-9100
7600 NORTHLAND DRIVE SE DECISION MADE: 21-DEC-00
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT DRAINAGE DEPOT
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K003078(TRADITIONAL)
ATTN: CHESTER MCCOY PHONE NO : 801-208-4404
1600 WEST MERIT PKWY. SE DECISION MADE: 11-DEC-00
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K003815(SPECIAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 27-DEC-00
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: MSD EMBOLECTOMY BASKET
METAMORPHIC SURGICAL DEVICES, LLC 510(k) NO: K991093(TRADITIONAL)
ATTN: GERALD G CANO PHONE NO : 412-826-5300
660 WILLIAM PITT WAY SE DECISION MADE: 21-DEC-00
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAIN COIL, MODEL 9800GE-64
MIDWEST R.F. LLC 510(k) NO: K003097(TRADITIONAL)
ATTN: RALPH S HASHOIAN PHONE NO : 262-367-6925
535 NORTON DR. SE DECISION MADE: 28-DEC-00
P.O. BOX 348 510(k) STATEMENT
HARTLAND, WI 53029
DEVICE: SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
MIDWEST R.F. LLC 510(k) NO: K003386(TRADITIONAL)
ATTN: RALPH S HASHOIAN PHONE NO : 262-367-6925
535 NORTON DR. SE DECISION MADE: 28-DEC-00
P.O. BOX 350 510(k) STATEMENT
HARTLAND, WI 53029
DEVICE: MILLENNIUM BLADES, MODEL MB101
MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K003143(TRADITIONAL)
ATTN: JERRY KAENI PHONE NO : 909-621-7646
360 EAST BONITA AVE. SE DECISION MADE: 11-DEC-00
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIADENT HDX/MMD HDX SP XRAY SENSOR
MULTI MEDIA DENTAL SYSTEMS, INC. 510(k) NO: K002425(TRADITIONAL)
ATTN: SCOTT MCLAUGHLIN PHONE NO : 877-770-8514
1302 MACY DR. SE DECISION MADE: 21-DEC-00
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXAN SYSTEM, MODEL NX-300
NEXAN LTD 510(k) NO: K003520(SPECIAL)
ATTN: DAVID L WEST PHONE NO : 301-272-3113
1801 ROCKVILLE PIKE SE DECISION MADE: 13-DEC-00
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTO
NIPRO MEDICAL CORP. 510(k) NO: K001465(TRADITIONAL)
ATTN: RICHARD D BLISS, JR. PHONE NO : 954-385-1690
510 STONEMONT DRIVE SE DECISION MADE: 05-DEC-00
WEST, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVOFINE 31 DISPOSABLE NEEDLE
NOVO NORODISK PHARMACEUTICALS INC 510(k) NO: K002403(TRADITIONAL)
ATTN: MICHAEL BARBUSH PHONE NO : 201-847-6451
100 OVERLOOK CENTER SUITE 200 SE DECISION MADE: 08-DEC-00
PRINCETON, NJ 08540-7810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
NUCLEAR DIAGNOSTICS AB 510(k) NO: K002782(TRADITIONAL)
ATTN: JIM HOWARD PHONE NO : 301-623-2500
11800 BALTIMORE AVENUE SE DECISION MADE: 05-DEC-00
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BELTSVILLE, MD 20705
DEVICE: PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066
NUCLETRON CORPORATION 510(k) NO: K003270(SPECIAL)
ATTN: ROBERT APPLEBAUM PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DRIVE SE DECISION MADE: 22-DEC-00
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
NUMED, INC. 510(k) NO: K003276(TRADITIONAL)
ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 01-DEC-00
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUMED Z-MED PTV CATHERERS
NUMED, INC. 510(k) NO: K003643(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 27-DEC-00
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN VENTILATOR
OCEANIC MEDICAL PRODUCTS, INC. 510(k) NO: K002951(TRADITIONAL)
ATTN: WILLIAM M GATES PHONE NO : 913-874-2000
8005 SHANNON INDUSTRIAL PARK SE DECISION MADE: 08-DEC-00
LN. 510(k) SUMMARY AVAILABLE FROM FDA
ATCHISON, KS 66002
DEVICE: SNARE,FLEXIBLE
ODON LIFETECHNOLOGY 510(k) NO: K002927(TRADITIONAL)
ATTN: J M DURAND PHONE NO : 331 472 21630
2 BIS RUE DU COMMANDANT PILOT SE DECISION MADE: 10-DEC-00
NEUILLY SUR SEINE, FRANCE 92200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
OLYMPUS AMERICA, INC. 510(k) NO: K003721(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 18-DEC-00
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: CAPNO PROBE A
OPTICAL SENSORS, INC. 510(k) NO: K984579(TRADITIONAL)
ATTN: GARY J SYRING PHONE NO : 608-877-2635
7615 GOLDEN TRIANGLE DR., SE DECISION MADE: 21-DEC-00
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: OPUS 20, MODEL 1ST
OPUSDENT LTD. 510(k) NO: K002899(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 12-DEC-00
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
ORASURE TECHNOLOGIES, INC. 510(k) NO: K001976(TRADITIONAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820
1745 EATON AVE SE DECISION MADE: 06-DEC-00
BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TKD SCALERS
ORASYSTEMS, LLC 510(k) NO: K000846(TRADITIONAL)
ATTN: BERNARD SESSMAN PHONE NO : 973-267-5632
764 SPEEDWELL AVE. SE DECISION MADE: 04-DEC-00
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
MORRIS PLAINS, NJ 07950-2231
DEVICE: PROCLUDE
ORTEK THERAPEUTICS, INC. 510(k) NO: K002989(TRADITIONAL)
ATTN: JULES T MITCHEL PHONE NO : 212-681-2100
305 MADISON AVENUE SE DECISION MADE: 14-DEC-00
SUITE 2501 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10165
DEVICE: ORTHOMATRIX, INC. CERCLAGE SYSTEM
ORTHOMATRIX, INC. 510(k) NO: K001254(TRADITIONAL)
ATTN: BEN SHAPPLEY PHONE NO : 901-888-5614
711 CHANEY COVE SE DECISION MADE: 13-DEC-00
COLLIERVILLE, TN 38017 510(k) STATEMENT
DEVICE: VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
ORTHOVITA CO. 510(k) NO: K994337(TRADITIONAL)
ATTN: ANGIE IDE PHONE NO : 610-640-1775
45 GREAT VALLEY PKWY. SE DECISION MADE: 14-DEC-00
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APPRAISE URINE MICROALBUMIN COLLECTION KIT
OSBORN GROUP, INC. 510(k) NO: K002156(TRADITIONAL)
ATTN: GILBERT P BOURK III PHONE NO : 913-390-7146
14901 WEST 117TH STREET SE DECISION MADE: 19-DEC-00
OLATHE, KS 66062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UBM PLUS, MODEL P45
PARADIGM MEDICAL INDUSTRIES, INC. 510(k) NO: K003141(SPECIAL)
ATTN: TRACY S BEST PHONE NO : 801-977-8970
2355 SOUTH 1070 WEST SE DECISION MADE: 05-DEC-00
SALT LAKE CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAFLUFOCON C AND E DAILY CONTACT LENS
PARAGON VISION SCIENCES 510(k) NO: K002845(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 08-DEC-00
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
PERMOBIL A.B. 510(k) NO: K993406(ABBREVIATED)
ATTN: BENGT PERSSON PHONE NO : 468 929 150
ENGELBREKTS VAG 101 SE DECISION MADE: 18-DEC-00
SOLLENTUNA, SWEDEN S-191 62 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K002942(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
710 BRIDGEPORT AVENUE SE DECISION MADE: 19-DEC-00
P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-0917
DEVICE: GYROSCAN INTERA 3.0T
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K003516(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
710 BRIDGEPORT AVE. SE DECISION MADE: 27-DEC-00
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHORMAX EAGLE SCANNER SYSTEM
PHORMAX CORP. 510(k) NO: K001499(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 27-DEC-00
LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGT
PLASTIMED LABORATOIRE PHARMACEUTIQ510(k) NO: K992424(TRADITIONAL)
ATTN: JEAN-DANIEL NURY PHONE NO : 011 331 34441515
95321 SAINT-LUE-LA-FORET SE DECISION MADE: 29-DEC-00
CEDEX, FRANCE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
PLUS ORTHOPEDICS 510(k) NO: K994146(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 11-DEC-00
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94553-3389
DEVICE: SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT,
POWERMED, INC. 510(k) NO: K003277(TRADITIONAL)
ATTN: MICHELE LUCEY PHONE NO : 866-769-3763
4 B EAST BRIDGE ST. SE DECISION MADE: 21-DEC-00
NEW HOPE, PA 18938 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
PROSURG, INC. 510(k) NO: K001576(TRADITIONAL)
ATTN: LEE BUI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 28-DEC-00
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS,
PST, INC. 510(k) NO: K003249(TRADITIONAL)
ATTN: WILLIAM NADEL PHONE NO : 650-849-2000
2462 EMBARCADERO WAY SE DECISION MADE: 12-DEC-00
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
PSYCHEMEDICS CORP. 510(k) NO: K000851(TRADITIONAL)
ATTN: WILLIAM THISTLE PHONE NO : 617-868-7455
1280 MASSACHUSETTS AVENUE SE DECISION MADE: 11-DEC-00
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02138
DEVICE: PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
PURE WATER SOLUTIONS, INC. 510(k) NO: K994279(ABBREVIATED)
ATTN: DEAN S LEWIS PHONE NO : 303-693-7610
14550 EAST EASTER AVENUE SE DECISION MADE: 22-DEC-00
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112
DEVICE: PENTRA 5D
R & D SYSTEMS, INC. 510(k) NO: K003534(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 612-379-2956
614 MCKINLEY PLACE N.E. SE DECISION MADE: 01-DEC-00
MINNEAPOLIS, MN 55413-2647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
R-GROUP INTL. 510(k) NO: K001233(TRADITIONAL)
ATTN: KERRY ANNE KAHN PHONE NO : 352-378-3633
2321 N.W. 66TH CT., SUITE W-4 SE DECISION MADE: 13-DEC-00
GAINESVILLE, FL 32653 510(k) STATEMENT
DEVICE: TCM400
RADIOMETER MEDICAL A/S 510(k) NO: K001866(SPECIAL)
ATTN: KRISTEN RONO PHONE NO : 453 827 3827
AKANDEVEJ 21 SE DECISION MADE: 07-DEC-00
DK-2700 BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MO
RETINALABS.COM 510(k) NO: K003036(TRADITIONAL)
ATTN: FRANK TIGHE PHONE NO : 800-793-1473
1776 PEACHTREE STREET SE DECISION MADE: 22-DEC-00
200 NORTH 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30309
DEVICE: MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003120(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 18-DEC-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS CK-MB
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003158(TRADITIONAL)
ATTN: KAY A TALOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 18-DEC-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS HCG AND BETA TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003178(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 14-DEC-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS DHEA-S CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003772(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 20-DEC-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL TERRAIN WHEELCHAIR (ATW)
ROLL-ABILITY (PTY) LTD. 510(k) NO: K003048(TRADITIONAL)
ATTN: VICTOR F MYBURGH PHONE NO : 540-776-0363
6162 STEEPLECHASE DRIVE SE DECISION MADE: 15-DEC-00
ROANOKE, VA 24018 510(k) STATEMENT
DEVICE: RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
RUDOLF RIESTER GMBH & CO. KG 510(k) NO: K002954(TRADITIONAL)
ATTN: PATRICIA RIESTER-FREUDENMANPHONE NO : 011 49 747792700
BRUCKSTRASSE 31 SE DECISION MADE: 21-DEC-00
P.O. BOX 35 510(k) SUMMARY AVAILABLE FROM FDA
JUNGINGEN, GERMANY D-72417
DEVICE: EMPIRE N BLOOD PRESSURE MANOMETERS
RUDOLF RIESTER GMBH & CO. KG 510(k) NO: K002955(TRADITIONAL)
ATTN: PATRICIA RIESTER-FREUDENMANPHONE NO : 011 49 747792700
BRUCKSTRASSE 31 SE DECISION MADE: 21-DEC-00
P.O. BOX 35 510(k) SUMMARY AVAILABLE FROM FDA
JUNGINGEN, GERMANY D-72417
DEVICE: SERUM PROTEIN SUBSTITUTE
SAGE BIOPHARMA 510(k) NO: K003734(SPECIAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 21-DEC-00
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MO
SCHAEFER WATER CENTERS 510(k) NO: K000249(TRADITIONAL)
ATTN: MICHAEL J SCHAEFER PHONE NO : 314-931-2268
HIGHWAY 61-67 SE DECISION MADE: 11-DEC-00
1555 COMERCIAL BLVD 510(k) SUMMARY AVAILABLE FROM FDA
HERCULANEUM, MO 63048
DEVICE: SCITON IMAGE HAIR REMOVAL LASER
SCITON, INC. 510(k) NO: K002853(TRADITIONAL)
ATTN: PETER ALLEN PHONE NO : 650-493-9155
845 COMMERCIAL AVE. SE DECISION MADE: 04-DEC-00
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL-TEC ELECTRODES
SEEDLING ENTERPRISES. LLC 510(k) NO: K002841(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 08-DEC-00
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
SEIN ELECTRONICS CO., LTD. 510(k) NO: K003711(TRADITIONAL)
ATTN: WON-KY KIM PHONE NO : 823 142 10389
133-3, PYUNGCHON-DONG SE DECISION MADE: 15-DEC-00
ANYANG-CITY, KYUNGGI-DO, REPUBLIC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHENLING ACUPUNCTURE NEEDLES
SHENLING MEDICAL DEVICE CO., LTD 510(k) NO: K002411(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748
1800 CENTURY PARK EAST SE DECISION MADE: 12-DEC-00
SUITE 600 510(k) STATEMENT
LOS ANGELES, CA 90067-1509
DEVICE: NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTI
SIAM SEMPERMED CORP. LTD. 510(k) NO: K002391(TRADITIONAL)
ATTN: WILLIAM HARRIS PHONE NO : 727-787-7250
30798 US HWY 19 NORTH SE DECISION MADE: 04-DEC-00
PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K002105(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVENUE SE DECISION MADE: 05-DEC-00
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETIC CONCERTO
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003192(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 21-DEC-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 900
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003243(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 21-DEC-00
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003246(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 21-DEC-00
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003248(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 21-DEC-00
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIREMOBIL ISO-C 3D
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003266(TRADITIONAL)
ATTN: AMY SHAW HOSLER PHONE NO : 732-321-4830
186 WOOD AVENUE SOUTH SE DECISION MADE: 01-DEC-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACTIVE REAL TIME SCANNING PACKAGE
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003623(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH SE DECISION MADE: 21-DEC-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
SIMS PORTEX, INC. 510(k) NO: K002506(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 14-DEC-00
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSABOND BONE CEMENT
SMITH & NEPHEW, INC. 510(k) NO: K001160(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 11-DEC-00
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
SMITH & NEPHEW, INC. 510(k) NO: K002747(ABBREVIATED)
ATTN: DAVID HENLEY PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 15-DEC-00
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY HA COATED POROUS FEMORAL STEMS
SMITH & NEPHEW, INC. 510(k) NO: K002996(ABBREVIATED)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 11-DEC-00
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPARTAN A-10
SPARTAN ULTRASONICS INC. 510(k) NO: K002753(TRADITIONAL)
ATTN: ALDO E EAGLE PHONE NO : 314-343-8300
1663 FENTON BUSINESS PARK CT. SE DECISION MADE: 04-DEC-00
FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY C
ST.JUDE MEDICAL 510(k) NO: K002976(TRADITIONAL)
ATTN: DEAN BRUHN-DING PHONE NO : 612-933-4700
14901 DEVEAU PLACE SE DECISION MADE: 22-DEC-00
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SW ULTRASOUND, MODELS 331, 311, 333
STARBENE 510(k) NO: K991613(TRADITIONAL)
ATTN: JUDITH NIZTZSCHMAMN PHONE NO : 543 514 240051
DAVID LUQUE 519 SE DECISION MADE: 08-DEC-00
CORDOBA, PVCIA. CORDOBA, ARGENTINA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR CLOSURE DEVICE
STD MFG., INC. 510(k) NO: K003169(TRADITIONAL)
ATTN: STEPHEN M PALUMBO PHONE NO : 781-828-4400
1063 TURNPIKE ST. SE DECISION MADE: 08-DEC-00
P.O. BOX 420 510(k) SUMMARY AVAILABLE FROM FDA
STOUGHTON, MA 02072
DEVICE: PROTRACT PRESS FIT HIP STEM
STELKAST CO. 510(k) NO: K003447(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINIAL ST. #210 SE DECISION MADE: 15-DEC-00
PITTSBURGH, PA 15212 510(k) STATEMENT
DEVICE: STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
STERITEC PRODUCTS, INC. 510(k) NO: K003002(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 08-DEC-00
CASTLE ROCK, CO 80104 510(k) STATEMENT
DEVICE: INJECTRITE-C15 AND INJECTRITE-C30
STERLING MEDIVATIONS, INC. 510(k) NO: K002127(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 952-473-7971
180 FERNDALE ROAD SOUTH SE DECISION MADE: 29-DEC-00
WAYZATA, MN 55391 510(k) STATEMENT
DEVICE: SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
STERLING MEDIVATIONS, INC. 510(k) NO: K003283(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 650-949-0470
180 FERNDALE ROAD SOUTH SE DECISION MADE: 13-DEC-00
WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEIBINGER NEURO CLIP SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K003660(SPECIAL)
ATTN: ROBIN L ROWE PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 12-DEC-00
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
STRYKER LEIBINGER 510(k) NO: K000594(TRADITIONAL)
ATTN: ROBIN L ROWE PHONE NO : 800-253-3210
4100 EAST MILHAM AVE SE DECISION MADE: 08-DEC-00
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKIE 2 POWER ASSIST WHEELCHAIR
SUNRISE MEDICAL, INC. 510(k) NO: K001491(TRADITIONAL)
ATTN: BRYAN DANNETTELL PHONE NO : 303-218-4500
7477 EAST DRY CREEK PKWY. SE DECISION MADE: 15-DEC-00
LONGMONT, CO 80503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
SURGICAL SPECIALTIES CORP. 510(k) NO: K003015(TRADITIONAL)
ATTN: VIKKI M HOFFMAN PHONE NO : 610-404-1000
100 DENNIS DRIVE SE DECISION MADE: 15-DEC-00
READING, PA 19606-3776 510(k) STATEMENT
DEVICE: NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
T. KOROS SURGICAL INSTRUMENTS CORP510(k) NO: K002755(TRADITIONAL)
ATTN: TIBOR KOROS PHONE NO : 805-529-0825
610 FLINN AVE. SE DECISION MADE: 04-DEC-00
MOORPARK, CA 93021 510(k) STATEMENT
DEVICE: NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES
TERANG NUSA SDN BHD 510(k) NO: K003545(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 21-DEC-00
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROT
TERANG NUSA SDN BHD 510(k) NO: K003547(TRADITIONAL)
ATTN: CHIN-GUAN LOW PHONE NO : 609 773 5133
1 JALAN 8, PENGKALAN CHEPA 2 SE DECISION MADE: 21-DEC-00
INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: PUMP TUBING WITH X-COATING
TERUMO CORP. 510(k) NO: K003371(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD SE DECISION MADE: 21-DEC-00
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANAIR/ CLEANWATER UNIT, MODEL 1600
TEXAS INSTITUTE FOR CONSERVATIVE D510(k) NO: K003265(TRADITIONAL)
ATTN: H.O. PIPKIN PHONE NO : 361-526-4699
702 OSAGE STREET SE DECISION MADE: 22-DEC-00
REFUGIO, TX 78377 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE,
THE OLYMPUS OPTICAL CO. 510(k) NO: K002749(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 04-DEC-00
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
THERASENSE, INC. 510(k) NO: K000582(TRADITIONAL)
ATTN: EVE CONNER PHONE NO : 510-749-5406
1360 SOUTH LOOP DR. SE DECISION MADE: 05-DEC-00
ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAGE THERMACOOL II SYSTEM
THERMAGE, INC. 510(k) NO: K003183(TRADITIONAL)
ATTN: KEITH MULLOWNEY PHONE NO : 510-782-2286
4058 POINT EDEN WAY SE DECISION MADE: 08-DEC-00
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND
THORATEC LABORATORIES CORP. 510(k) NO: K001927(TRADITIONAL)
ATTN: DONALD A MIDDLEBROOK PHONE NO : 925-847-8600
6035 STONERIDGE DR. SE DECISION MADE: 18-DEC-00
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUELINK BIPOLAR FORCEPS
TISSUELINK MEDICAL INC. 510(k) NO: K003005(TRADITIONAL)
ATTN: ROBERTA L THOMPSON PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 08-DEC-00
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
TORNIER S.A. 510(k) NO: K003728(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 20-DEC-00
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: X-POSURE SYSTEM VERSION 2 MAMMO
TORSANA OSTEOPOROSIS DIAGNOSTICS A510(k) NO: K003656(SPECIAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 13TH STREET, N.W. SE DECISION MADE: 15-DEC-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIU
TRIMEDYNE, INC. 510(k) NO: K002308(TRADITIONAL)
ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300
2801 BARRANCA RD. SE DECISION MADE: 20-DEC-00
P.O. BOX 57001 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92606
DEVICE: CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
TZ MEDICAL, INC. 510(k) NO: K001634(TRADITIONAL)
ATTN: BYRON ZAHLER PHONE NO : 503-639-0282
15858 S.W. UPPER BOONES FERRY SE DECISION MADE: 21-DEC-00
RD. 510(k) SUMMARY AVAILABLE FROM FDA
LAKE OSWEGO, OR 97035
DEVICE: U1 HIP SYSTEM
UNITED ORTHOPEDIC CORP. 510(k) NO: K994078(TRADITIONAL)
ATTN: MELLEN LIU PHONE NO : 886 35 773351 28
57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 04-DEC-00
HSINCHU, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
UNITED STATES SURGICAL, A DIVISION510(k) NO: K001895(TRADITIONAL)
ATTN: ERIKA J MILLER PHONE NO : 203-845-4501
150 GLOVER AVE. SE DECISION MADE: 08-DEC-00
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DARDIK CAROTID SHUNT
VASCUTECH, INC. 510(k) NO: K001621(TRADITIONAL)
ATTN: TRENT G KAMKE PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE SE DECISION MADE: 06-DEC-00
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: EECP THERAPY SYSTEM, MODEL TS3
VASOMEDICAL, INC. 510(k) NO: K003469(SPECIAL)
ATTN: THOMAS R VARRICCHIONE PHONE NO : 516-997-4600
180 LINDEN AVE. SE DECISION MADE: 06-DEC-00
WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V SCORE WITH AUTO GATE MODEL TBD
VITAL IMAGES, INC. 510(k) NO: K003230(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001
3300 FERNBROOK LANE NORTH SE DECISION MADE: 27-DEC-00
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: VIVANT BREAST LESION LOCALIZATION DEVICE
VIVANT MEDICAL, INC. 510(k) NO: K003439(TRADITIONAL)
ATTN: GEORGE HERMANN PHONE NO : 650-529-1238
3210-B ALPINE ROAD SE DECISION MADE: 15-DEC-00
PORTOLA VALLEY, CA 94028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIS ADJUSTABLE CONSTRICTION LOOP
VIVUS, INC. 510(k) NO: K003115(TRADITIONAL)
ATTN: CAROL D KARP PHONE NO : 650-934-5224
1172 CASTRO ST. SE DECISION MADE: 19-DEC-00
MOUNTAIN VIEW, CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VNUS CLOSURE SYSTEM
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K003092(SPECIAL)
ATTN: SAM NANAVATI PHONE NO : 408-747-1200
238 EAST CARIBBEAN DR. SE DECISION MADE: 18-DEC-00
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-L
WECK CLOSURE SYSTEMS 510(k) NO: K003337(TRADITIONAL)
ATTN: BRIAN YOUNG PHONE NO : 919-361-4041
1 WECK DR. SE DECISION MADE: 21-DEC-00
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-FEMUR R
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K003016(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-9971
5677 AIRLINE RD. SE DECISION MADE: 13-DEC-00
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XISCAN 6000 IMAGING SYSTEM
XITEC INC. 510(k) NO: K003568(TRADITIONAL)
ATTN: SHEILA M HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 27-DEC-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
XLTEK 510(k) NO: K002969(TRADITIONAL)
ATTN: DEBBIE DAVY PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 08-DEC-00
OAKVILLE, CANADA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 30 CLASSIC PNEUMATONOMETER
XOMED, INC. 510(k) NO: K002395(TRADITIONAL)
ATTN: DIANA PRESTON PHONE NO : 904-332-8959
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 11-DEC-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
XOMED, INC. 510(k) NO: K002987(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 04-DEC-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROLAB PLUS
Z-KAT, INC. 510(k) NO: K002893(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2903 SIMMS STREET SE DECISION MADE: 04-DEC-00
HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTG - MINITUB HEATED STAGE SYSTEMS
ZANDER MEDICAL SUPPLIES, INC. 510(k) NO: K002971(TRADITIONAL)
ATTN: FRIEDEL MW ZANDER PHONE NO : 561-569-5955
755 8TH CT., SUITE #4 SE DECISION MADE: 15-DEC-00
P.O.650790 510(k) SUMMARY AVAILABLE FROM FDA
VERO BEACH, FL 32965-0790
DEVICE: ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-
ZCV ,INC. 510(k) NO: K002481(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 732-225-3800
298 FERNWOOD AVE. SE DECISION MADE: 07-DEC-00
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z
ZCV ,INC. 510(k) NO: K003118(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 732-225-3800
298 FERNWOOD AVE. SE DECISION MADE: 20-DEC-00
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
ZIMMER, INC. 510(k) NO: K002960(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 219-267-6131
P.O. BOX 708 SE DECISION MADE: 11-DEC-00
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 262
TOTAL WITH SUMMARIES 218
TOTAL WITH STATEMENTS 44
Updated 11/26/02
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