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510(k)s Final Decisions Rendered for June 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-JUN-2001 THROUGH 30-JUN-2001
DEVICE: GILB, MODEL 8010
3M CO. 510(k) NO: K011200(TRADITIONAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326
3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 14-JUN-01
ST PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOL
ABBOTT LABORATORIES 510(k) NO: K010553(TRADITIONAL)
ATTN: JANET CONNOLLY PHONE NO : 781-276-6230
4-A CROSBY DR. SE DECISION MADE: 18-JUN-01
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
ABBOTT LABORATORIES 510(k) NO: K010953(TRADITIONAL)
ATTN: JOHN DEAN PHONE NO : 408-567-3430
5440 PATRICK HENRY DR. SE DECISION MADE: 06-JUN-01
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
ABBOTT LABORATORIES 510(k) NO: K011442(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
DEPT 37K BLDG AP30 SE DECISION MADE: 05-JUN-01
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064
DEVICE: GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
ACCUFAST, INC. 510(k) NO: K011752(TRADITIONAL)
ATTN: DON LOGAN PHONE NO : 204 837 8366
251 CREE CRESCENT SE DECISION MADE: 28-JUN-01
WINNIPEG, MANITOBA, CANADA R3J 3X4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYPRESS SYSTEM
ACUSON CORP. 510(k) NO: K010950(ABBREVIATED)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH ST., N.W. SE DECISION MADE: 27-JUN-01
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
ADSIS LTD. 510(k) NO: K010791(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 08-JUN-01
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEM
ADVANCED RENAL TECHNOLOGIES, INC. 510(k) NO: K010760(TRADITIONAL)
ATTN: ROBIN CALLAN PHONE NO : 425-825-1276
11838 N.E. 112TH ST. SE DECISION MADE: 11-JUN-01
KIRKLAND, WA 98033 510(k) STATEMENT
DEVICE: OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
ADVANCED SURGICAL CONCEPTS (ASC) 510(k) NO: K011183(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 15-JUN-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K010921(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 650-569-3852
1201 DOUGLAS AVE. SE DECISION MADE: 25-JUN-01
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
AESCULAP, INC. 510(k) NO: K003759(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 28-JUN-01
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389
DEVICE: AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
AESCULAP, INC. 510(k) NO: K010752(TRADITIONAL)
ATTN: LESLIE YOUNG PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 11-JUN-01
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
AESCULAP, INC. 510(k) NO: K011375(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 29-JUN-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREA
AGILENT TECHNOLOGIES, INC. 510(k) NO: K010634(TRADITIONAL)
ATTN: RICHARD J PETERSEN PHONE NO : 978-659-2213
3000 MINUTEMAN RD. SE DECISION MADE: 11-JUN-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K011578(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD., MS 0491 SE DECISION MADE: 08-JUN-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-LINE AEP MONITOR
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K010965(TRADITIONAL)
ATTN: RENEE FLUET PHONE NO : 858-458-7563
10221 WATERIDGE CIRCLE SE DECISION MADE: 27-JUN-01
SAN DIEGO, CA 92121-2733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLEY SP02 MODULE, MODEL 8220
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K010966(TRADITIONAL)
ATTN: RENEE L FLUET PHONE NO : 858-458-7845
10221 WATERIDGE CIRCLE SE DECISION MADE: 08-JUN-01
SAN DIEGO, CA 92121-2733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PR
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K010862(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 07-JUN-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRLIFE HEPA FILTER
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K011132(SPECIAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. SE DECISION MADE: 08-JUN-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT L
AMERICAN BIOCURVE, INC. 510(k) NO: K011234(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DR. SE DECISION MADE: 13-JUN-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT L
AMERICAN CONTACT LENS, INC. 510(k) NO: K011316(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 13-JUN-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS SLING FIXATION SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K010990(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6309
10700 BREN RD., WEST SE DECISION MADE: 22-JUN-01
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX
AMERICAN TELECARE, INC. 510(k) NO: K003999(TRADITIONAL)
ATTN: CHARLES RICHARD ABBRUSCATO PHONE NO : 952-897-0000
7640 GOLDEN TRIANGLE DR. SE DECISION MADE: 28-JUN-01
EDEN PRAIRIE, MN 55344-3732 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM COMPRESSION ANCHOR SYSTEM
ANCHOR MEDICAL TECHNOLOGIES 510(k) NO: K010884(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 20-JUN-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GL
ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K011593(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, SE SE DECISION MADE: 21-JUN-01
MASSILLON, OH 44646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESTEP MDMA (ECSTASY) DRUG SCREEN TEST
APPLIED BIOTECH, INC. 510(k) NO: K011133(TRADITIONAL)
ATTN: DAVE D SMITH PHONE NO : 858-713-9614
10237 FLANDERS CT. SE DECISION MADE: 20-JUN-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: SEP-10S PLUS, AND SP-12S PRO.
ARAZY GROUP 510(k) NO: K010937(TRADITIONAL)
ATTN: KOBY BEN-BARAK PHONE NO : 972 049 9477880
MITZPE AVIV INDUSTRIAL PARK 13 SE DECISION MADE: 25-JUN-01
M.P. MISGAV, ISRAEL 20187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENA
ARDO MEDICAL AG 510(k) NO: K011601(TRADITIONAL)
ATTN: EVA KRAHENBUHL PHONE NO : 417 547 070 \
GEWERBESTRASSE 19 SE DECISION MADE: 08-JUN-01
UNTERAGERI, SWITZERLAND CH-6314 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BREAST-BOARD (MULTIPLE)
ARPLAY MEDICAL S.A. 510(k) NO: K003778(TRADITIONAL)
ATTN: RICHARD BORGI PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX SE DECISION MADE: 08-JUN-01
IZEURE, COTE D'OR, FRANCE 21110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
ARTERIA MEDICAL SCIENCE, INC. 510(k) NO: K001917(TRADITIONAL)
ATTN: STEVE CHERNOFF PHONE NO : 425-861-8262
P.O. BOX 3515 SE DECISION MADE: 06-JUN-01
REDMOND, WA 98073-3515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
ARTHREX, INC. 510(k) NO: K011007(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 12-JUN-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX BIO-TRANSFIX
ARTHREX, INC. 510(k) NO: K011172(TRADITIONAL)
ATTN: VERNON BROWN PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 19-JUN-01
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD
ARTHROCARE CORP. 510(k) NO: K011083(TRADITIONAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 28-JUN-01
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H097
ARTHROCARE CORP. 510(k) NO: K011634(SPECIAL)
ATTN: BETTY M JOHNSON PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 19-JUN-01
SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K011534(SPECIAL)
ATTN: CHRISTINE M VOZELLA PHONE NO : 617-559-7028
141 NEEDHAM STREET SE DECISION MADE: 15-JUN-01
NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPARROWHAWK DISPOSABLE
ATC TECHNOLOGIES, INC. 510(k) NO: K010473(TRADITIONAL)
ATTN: PAUL KIERCE PHONE NO : 781-939-0725
80 CUMMINGS PARK SE DECISION MADE: 06-JUN-01
WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
AUTOMATIC MEDICAL TECHNOLOGIES, IN510(k) NO: K002409(TRADITIONAL)
ATTN: MICHAEL MITSUNAGA PHONE NO : 323-735-3811
3422 WEST PICO BLVD. SE DECISION MADE: 28-JUN-01
LOS ANGELES, CA 90019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K'FIX
AVANTA ORTHOPAEDICS, INC. 510(k) NO: K010847(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-452-8580
9369 CARROLL PARK RD., SUITE A SE DECISION MADE: 19-JUN-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIAL HEAD IMPLANT
AVANTA ORTHOPAEDICS, INC. 510(k) NO: K011819(SPECIAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-452-8580
9369 CARROLL PARK RD., SUITE A SE DECISION MADE: 19-JUN-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOME HEALTH MONITORING SYSTEM
AVID CARE CORP. 510(k) NO: K010029(TRADITIONAL)
ATTN: WILLIAM GENTHE PHONE NO : 414-291-0844
152 WEST WISCONSIN AVE. SE DECISION MADE: 29-JUN-01
SUITE 930 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53203
DEVICE: UNIQUE AMBULATORY EEG
AXON SYSTEMS, INC. 510(k) NO: K010697(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112
400-2200 OSER AVE. SE DECISION MADE: 06-JUN-01
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER, TYPE 2102
B-K MEDICAL A/S 510(k) NO: K011417(TRADITIONAL)
ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100
SANDTOFTEN 9 SE DECISION MADE: 08-JUN-01
GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
BACCHUS VASCULAR, INC. 510(k) NO: K003570(TRADITIONAL)
ATTN: ROBERT A CLARK PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 06-JUN-01
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
BARRIERMED, INC. 510(k) NO: K011446(TRADITIONAL)
ATTN: CARLO PONCIPE PHONE NO : 407-323-1604
2500 WEST LAKE MARY BLVD. SE DECISION MADE: 14-JUN-01
LAKE MARY, FL 32746 510(k) STATEMENT
DEVICE: MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAI
BAXTER HEALTHCARE CORP. 510(k) NO: K011317(TRADITIONAL)
ATTN: VICKI L DREWS PHONE NO : 847-270-5916
RT. 120 AND WILSON ROAD SE DECISION MADE: 28-JUN-01
ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD SPRING BASED SYRINGE
BD 510(k) NO: K011103(TRADITIONAL)
ATTN: GREG W MORGAN PHONE NO : 201-847-4344
1 BECTON DR. MC 226 SE DECISION MADE: 13-JUN-01
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLINK THREADED LOCK CANNULA
BD 510(k) NO: K011858(SPECIAL)
ATTN: GREGORY W MORGAN PHONE NO : 201-847-4344
1 BECTON DR. MC 226 SE DECISION MADE: 19-JUN-01
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTEC MGIT 960 SIR KITS
BD BECTON DICKINSON VACUTAINER SYS510(k) NO: K003062(TRADITIONAL)
ATTN: DENNIS R MERTZ PHONE NO : 410-316-4192
7 LOVETON CIR. SE DECISION MADE: 06-JUN-01
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SY
BECKMAN COULTER, INC. 510(k) NO: K003259(TRADITIONAL)
ATTN: DENISE THOMPSON PHONE NO : 612-368-1202
1000 LAKE HAZELTINE DR. SE DECISION MADE: 13-JUN-01
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K010429(TRADITIONAL)
ATTN: BRENT TABER PHONE NO : 952-368-1323
1000 LAKE HAZELTINE DR. SE DECISION MADE: 05-JUN-01
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PR
BECKMAN COULTER, INC. 510(k) NO: K011465(SPECIAL)
ATTN: MARY B TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 08-JUN-01
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABELL, MODEL 4200
BELL DENTAL PRODUCTS, LLC. 510(k) NO: K011222(TRADITIONAL)
ATTN: DAN BELL PHONE NO : 303-292-2137
3003 ARAPAHOE ST., #101-B SE DECISION MADE: 25-JUN-01
DENVER, CO 80205 510(k) STATEMENT
DEVICE: LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNO
BIO-RAD LABORATORIES 510(k) NO: K011494(TRADITIONAL)
ATTN: DONNA CHAPMAN PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 08-JUN-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
BIO-RAD LABORATORIES 510(k) NO: K011579(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1465
9500 JERONIMO RD. SE DECISION MADE: 26-JUN-01
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE AUTOTAC SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K011675(SPECIAL)
ATTN: DONALD E DALTON PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 22-JUN-01
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K010209(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 12-JUN-01
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: RESORBABLE HAMMERTOE PIN
BIOMET, INC. 510(k) NO: K011137(TRADITIONAL)
ATTN: SARA A BAILEY PHONE NO : 219-372-1568
P.O. BOX 587 SE DECISION MADE: 19-JUN-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRETT UNICONDYLAR TIBIAL BEARING
BIOMET, INC. 510(k) NO: K011509(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 13-JUN-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
BIOMET, INC. 510(k) NO: K011554(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 26-JUN-01
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WORLAND UNICONDYLAR TIBIAL BEARING
BIOMET, INC. 510(k) NO: K011795(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 13-JUN-01
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLLA PIN
BIONX IMPLANTS, INC. 510(k) NO: K010983(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 3 3165679
HERMIANKATU 6-8 L SE DECISION MADE: 13-JUN-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYBELL
BIOPSYBELL S.A.S. 510(k) NO: K011075(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 860-633-8807
131 HIGHWOOD DRIVE SE DECISION MADE: 27-JUN-01
SOUTH GLASTONBURY, CT 06073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE-STEP PLUS
BISCO, INC. 510(k) NO: K011159(TRADITIONAL)
ATTN: CYNDY ORIS PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 08-JUN-01
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F MACH 1, MODEL 34356-XXX
BOSTON SCIENTIFIC CORP. 510(k) NO: K010874(TRADITIONAL)
ATTN: TODD KORNMANN PHONE NO : 763-694-5857
ONE SCIMED PLACE SE DECISION MADE: 21-JUN-01
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WI
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K010856(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 06-JUN-01
BATU BELAH, KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
C.R. BARD, INC. 510(k) NO: K011015(TRADITIONAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 22-JUN-01
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABL
CALIFORNIA MEDICAL LABORATORIES, I510(k) NO: K010974(TRADITIONAL)
ATTN: MEHMET BICAKCI PHONE NO : 714-556-7365
1570 SUNLAND LANE SE DECISION MADE: 18-JUN-01
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHESS HAND SURGERY SYSTEM
CANICA DESIGN, INC. 510(k) NO: K010184(TRADITIONAL)
ATTN: GEORGETTE ROY PHONE NO : 613 256 0350
36 MILL STREET SE DECISION MADE: 22-JUN-01
ALMONTE, ONTARIO, CANADA KOA1AO 510(k) STATEMENT
DEVICE: HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
CANTERBURY HEALTH LABORATORIES 510(k) NO: K011389(TRADITIONAL)
ATTN: MAURICE OWEN PHONE NO : 643 364 0546
HAGLEY AVENUE SE DECISION MADE: 21-JUN-01
CHRISTCHURCH, CANTERBURY, NEW ZEAL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
CHEEN HOUNG ENT. CO. LTD. 510(k) NO: K003927(TRADITIONAL)
ATTN: JAY WANG PHONE NO : 011 886 226892001
23 ALLEY 11 LANE 65 SAN DREEN SE DECISION MADE: 26-JUN-01
STREET 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI (SHULIN), CHINA (TAIWAN) 23805
DEVICE: CLARREN HELMET
CHILDREN'S HOSPITAL & MEDICAL CENT510(k) NO: K003035(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301 K STREET, N.W. SE DECISION MADE: 06-JUN-01
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MA
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K011336(TRADITIONAL)
ATTN: KEITH PAULCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 12-JUN-01
DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT/MASTER, VERSION 1.0
COLUMBIA SCIENTIFIC, INC. 510(k) NO: K011180(SPECIAL)
ATTN: CHARLES D STOCKHAM PHONE NO : 410-964-3110
8940 OLD ANNAPOLIS RD. SE DECISION MADE: 27-JUN-01
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: OIL FOR TISSUE CULTURE
CONCEPTION TECHNOLOGIES 510(k) NO: K011462(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 13-JUN-01
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWT
CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K011677(SPECIAL)
ATTN: RONALD KOHLHARDT PHONE NO : 408-727-3240
3150 CENTRAL EXPRESSWAY SE DECISION MADE: 22-JUN-01
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
COOK VASCULAR, INC. 510(k) NO: K010055(TRADITIONAL)
ATTN: THEODORE HEISE PHONE NO : 765-463-7537
RT. 66, RIVER RD. SE DECISION MADE: 14-JUN-01
P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA
LEECHBURG, PA 15656
DEVICE: CORDIS M3 PTA DILATATION CATHETER
CORDIS CORP. 510(k) NO: K003920(ABBREVIATED)
ATTN: CHARLES (CHUCK) J RYAN PHONE NO : 908-412-7446
7 POWDERHORN DRIVE SE DECISION MADE: 15-JUN-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL
CORDIS CORP. 510(k) NO: K010083(TRADITIONAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDERHORN DRIVE SE DECISION MADE: 06-JUN-01
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLL
DADE BEHRING, INC. 510(k) NO: K002885(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 21-JUN-01
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
DADE BEHRING, INC. 510(k) NO: K011033(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 07-JUN-01
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION DRUG CALIBRATOR, MODEL DC22B
DADE BEHRING, INC. 510(k) NO: K011035(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 14-JUN-01
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: EMS 3000
DAN MED, INC. 510(k) NO: K010745(TRADITIONAL)
ATTN: THOMAS SANDGAARD PHONE NO : 800-495-6670
4 WEST DRY CREEK CIRCLE, SE DECISION MADE: 27-JUN-01
SUITE 260 510(k) STATEMENT
DENVER, CO 80120
DEVICE: CARDIOCAM MODEL 9CSY0799
DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K011611(TRADITIONAL)
ATTN: NIELS S ORENSEN PHONE NO : 454 576 8888
DR. NEERGAARDSVEJ 5F SE DECISION MADE: 08-JUN-01
2970 HORSHOM, DENMARK 2970 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (W
DATEX-OHMEDA 510(k) NO: K011670(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 978-640-0469
THREE HIGHWOOD DRIVE SE DECISION MADE: 26-JUN-01
TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELDENT ULTRASONIC INSERTS
DELDENT LTD. 510(k) NO: K011179(TRADITIONAL)
ATTN: ALAN EDEL PHONE NO : 039 049 668
19 KEREN KAYEMET STREET SE DECISION MADE: 05-JUN-01
PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT
DEVICE: CARMEN
DENTAURUM, INC. 510(k) NO: K011425(TRADITIONAL)
ATTN: THOMAS J ANDERSON PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 05-JUN-01
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRICERAM
DENTAURUM, INC. 510(k) NO: K011428(TRADITIONAL)
ATTN: THOMAS J ANDERSON PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 05-JUN-01
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
DENVER BIOMEDICAL, INC. 510(k) NO: K011831(SPECIAL)
ATTN: BONNIE VIVIAN PHONE NO : 303-279-7500
14998 WEST 6TH AVE., BLDG.E700 SE DECISION MADE: 28-JUN-01
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
DENVER BIOMEDICALS, INC. 510(k) NO: K011020(SPECIAL)
ATTN: NANCY SAUER PHONE NO : 303-665-9423
401 SPRUCE STREET SE DECISION MADE: 01-JUN-01
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLA BAND CLAMP
DEPUY ACROMED 510(k) NO: K010972(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 12-JUN-01
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PFC SIGMA LUGGED TIBIAL TRAY
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003026(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 19-JUN-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: TROCHANTERIC NAIL
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K010780(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 12-JUN-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011047(TRADITIONAL)
ATTN: MARCIA ARENTZ PHONE NO : 219-267-8143
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JUN-01
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCEL FRACTURE CEMENTED HIP STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011367(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 219-371-4905
700 ORTHOPAEDIC DR. SE DECISION MADE: 15-JUN-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: ORTHOGENESIS LPS SYSTEM
DEPUY, INC. 510(k) NO: K003182(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 27-JUN-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: STA-LIATEST FREE PROTEIN S TEST KIT
DIAGNOSTICA STAGO, INC. 510(k) NO: K010963(TRADITIONAL)
ATTN: ANDREW LOC B LE PHONE NO : 973-631-1200
5 CENTURY DR. SE DECISION MADE: 06-JUN-01
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
DIAGNOSTICA-STAGO 510(k) NO: K010455(TRADITIONAL)
ATTN: ANDREW LOC B LE PHONE NO : 973-631-1200
5 CENTURY DRIVE SE DECISION MADE: 07-JUN-01
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QP
DIGIRAD CORP. 510(k) NO: K011572(TRADITIONAL)
ATTN: COREY STEWART PHONE NO : 858-537-2118
9350 TRADE PLACE SE DECISION MADE: 15-JUN-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K010901(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 19-JUN-01
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K010988(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 19-JUN-01
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K011390(SPECIAL)
ATTN: ELAD MAGAL PHONE NO : 972 9 9511511
3 HASADNOAT ST. SE DECISION MADE: 06-JUN-01
HERZLIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
DMG USA, INC. 510(k) NO: K011211(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 18-JUN-01
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER LITHOTRIPTER 140("DOLI 140")
DORNIER 510(k) NO: K011773(SPECIAL)
ATTN: SUZANNE COURTNEY PHONE NO : 770-514-6204
1155 ROBERTS BOULEVARD SE DECISION MADE: 22-JUN-01
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVINA
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K003068(TRADITIONAL)
ATTN: JIM BRENNAN PHONE NO : 215-721-5400
3136 QUARRY ROAD SE DECISION MADE: 25-JUN-01
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K010093(TRADITIONAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3136 QUARRY ROAD SE DECISION MADE: 14-JUN-01
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLA 700,SOLA 500, SOLA 300
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K010724(ABBREVIATED)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 07-JUN-01
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRACHYSEED PD-103 MODELS #PD1
DRAXIMAGE, INC. 510(k) NO: K011119(ABBREVIATED)
ATTN: RICHARD J FLANAGAN PHONE NO : 514 630 7039
16751 TRANS CANADA HIGHWAY SE DECISION MADE: 25-JUN-01
KIRKLAND, QC, CANADA H9H 4J4 510(k) STATEMENT
DEVICE: INTER-VIAL
DUOJECT MEDICAL SYSTEMS, INC. 510(k) NO: K010703(TRADITIONAL)
ATTN: DANIEL MACDONALD PHONE NO : 450 534 3666
50 RUE DE GASPE COMPLEX B-5 SE DECISION MADE: 25-JUN-01
BROMONT, QC., CANADA J2L 2N8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRODOSE CATH, MODELS 90121-201, -202, -203
DURECT CORP. 510(k) NO: K011383(SPECIAL)
ATTN: JEFF P MILLER PHONE NO : 408-864-7409
10240 BUBB RD. SE DECISION MADE: 25-JUN-01
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
DYSPHAGIA, L.L.C. 510(k) NO: K002410(TRADITIONAL)
ATTN: MARCY FREED PHONE NO : 216-831-8384
3011 KERSDALE ROAD SE DECISION MADE: 06-JUN-01
CLEVELAND, OH 44124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX ACCESS PELVIC FIXATOR
EBI, L.P. 510(k) NO: K011697(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 27-JUN-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
EBI, L.P. 510(k) NO: K011711(SPECIAL)
ATTN: PATRICIA FLOOD PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 29-JUN-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT FLOW SYSTEM, MODEL M672P
EME (ELECTRO MEDICAL EQUIPMENT) LT510(k) NO: K011516(TRADITIONAL)
ATTN: STUART CORNER PHONE NO : 011 44 1273645100
60 GLADSTONE PLACE SE DECISION MADE: 08-JUN-01
BRIGHTON, SUSSEX, UNITED KINGDOM B510(k) STATEMENT
DEVICE: TRI-FIX SPINAL FIXATION SYSTEM
ENDIUS, INC. 510(k) NO: K010903(TRADITIONAL)
ATTN: GENE DIPOTO PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 06-JUN-01
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-FIX SPINAL FIXATION SYSTEM
ENDIUS, INC. 510(k) NO: K010922(TRADITIONAL)
ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 06-JUN-01
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCARE CARDIAC SURGICAL SYSTEM
ENDOCARE, INC. 510(k) NO: K011040(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424
7 STUDEBAKER SE DECISION MADE: 15-JUN-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
ENTRACON CORP. 510(k) NO: K011587(TRADITIONAL)
ATTN: PAUL ZANNECHIA PHONE NO : 888-369-3644
22 WINDSOR DR. SE DECISION MADE: 01-JUN-01
FOXBOROUGH, MA 02035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: JET SYRINGE MODEL-100500
EQUIDYNE SYSTEMS, INC. 510(k) NO: K003741(TRADITIONAL)
ATTN: JIM BARLEY PHONE NO : 858-451-7001
11770 BERNARDO PLAZA CT. SE DECISION MADE: 01-JUN-01
SUITE 351 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
ESPE DENTAL AG 510(k) NO: K011394(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 29-JUN-01
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112
ETHICON ENDO-SURGERY, INC. 510(k) NO: K010870(TRADITIONAL)
ATTN: DENNIS HAHN PHONE NO : 513-337-3134
4545 CREEK RD. SE DECISION MADE: 18-JUN-01
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
EUROMI SA 510(k) NO: K010311(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 29-JUN-01
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEJET PRINTER 400
FERRANIA S.P.A. STABILIMENTO DI FE510(k) NO: K011617(TRADITIONAL)
ATTN: RICCARDO GENTA PHONE NO : 390 195 221
57 VIALE DELLA LIBERTA SE DECISION MADE: 08-JUN-01
FERRANIA, SAVONA, ITALY 17014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RESTORE-PF VIC; RESTORE-PF VLC CAPSULE
FIRST SCIENTIFIC LIMITED 510(k) NO: K011295(TRADITIONAL)
ATTN: ADE AKINMADE PHONE NO : 44 149 5320456
7 ROSEHEYWORTH BUSINESS PARK SE DECISION MADE: 27-JUN-01
ABERTILLERY 510(k) STATEMENT
BLAENAU GWENT, WALES, UNITED KINGDOM NP13 1SP
DEVICE: LUTE VLC; CORE VLC
FIRST SCIENTIFIC LIMITED 510(k) NO: K011309(TRADITIONAL)
ATTN: ADE AKINMADE PHONE NO : 44 149 5320456
7 ROSEHEYWORTH BUSINESS PARK SE DECISION MADE: 22-JUN-01
ABERTILLERY 510(k) STATEMENT
BLAENAU GWENT, WALES, UNITED KINGDOM NP13 1SP
DEVICE: ORACLE ORAL MASK
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K003894(TRADITIONAL)
ATTN: DARRYN ALEXANDER PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 25-JUN-01
EAST TAMAKI 510(k) SUMMARY AVAILABLE FROM FDA
AUCKLAND, NEW ZEALAND
DEVICE: RESPIRATORY HUMIDIFIER, MODEL HC150
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K003973(TRADITIONAL)
ATTN: CHRIS MANDER PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 01-JUN-01
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
FONAR CORP. 510(k) NO: K011485(SPECIAL)
ATTN: LUCIANO BONANNI PHONE NO : 631-694-2929
110 MARCUS DR., 102 MARCUS DR. SE DECISION MADE: 06-JUN-01
& 405 SMITH ST. 510(k) SUMMARY AVAILABLE FROM FDA
MELVILLE, NY 11747
DEVICE: CONTINUOUS FLOW Y-TUBING
G.U.-TEK 510(k) NO: K010122(TRADITIONAL)
ATTN: ANTHONY SOLAZZO PHONE NO : 908-412-1200
904 OAK TREE AVE. SE DECISION MADE: 04-JUN-01
SUITE I 510(k) STATEMENT
SOUTH PLAINFIELD, NJ 07080
DEVICE: GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
GAMBRO RENAL PRODUCTS 510(k) NO: K010667(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018
10810 W. COLLINS AVE. SE DECISION MADE: 04-JUN-01
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIO 500D R&F; X-RAY SYSTEM
GE MEDICAL SYSTEM 510(k) NO: K011624(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N GRANDVIEW BLVD SE DECISION MADE: 08-JUN-01
W-709 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: BALLERT CRANIAL MOLDING HELMET
GEMA, INC. 510(k) NO: K011433(TRADITIONAL)
ATTN: GENE BERNARDONI PHONE NO : 773-878-2445
2434 W. PETERSON AVENUE SE DECISION MADE: 12-JUN-01
CHICAGO, IL 60659 510(k) STATEMENT
DEVICE: IMMUNOWELL EA (D) IGG TEST
GENBIO 510(k) NO: K010301(TRADITIONAL)
ATTN: BRYAN KIEHL PHONE NO : 858-592-9300
15222 AVE. OF SCIENCE, SUITE A SE DECISION MADE: 11-JUN-01
SAN DIEGO, CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAM 2001 MODULE
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K011000(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 29-JUN-01
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERATHERM BABYWATCH TEMPERATURE MONITOR
GERATHERM AG 510(k) NO: K001281(TRADITIONAL)
ATTN: ED HOLTER PHONE NO : 248-351-6237
2000 TOWN CENTER SE DECISION MADE: 12-JUN-01
SUITE 1900 510(k) SUMMARY AVAILABLE FROM FDA
SOUTHFIELD, MI 48075-2645
DEVICE: THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
GO MEDICAL INDUSTRIES PTY. LTD. 510(k) NO: K011055(TRADITIONAL)
ATTN: GEORGE O'NEIL PHONE NO : 618 938 81991
200 CHURCHILL AVE. SE DECISION MADE: 06-JUN-01
SUBIACO, PERTH, AUSTRALIA 6008 510(k) STATEMENT
DEVICE: VACUETTE EVACUATED BLOOD COLLECTION TUBES
GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K011699(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
SE DECISION MADE: 28-JUN-01
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIATOR PERIPHERAL DILATATION CATHETER
GUIDANT CORP. 510(k) NO: K010831(SPECIAL)
ATTN: MERRITT GIRGIS PHONE NO : 909-914-2631
26531 YNEZ RD. SE DECISION MADE: 13-JUN-01
P.O. BOX 9018 510(k) SUMMARY AVAILABLE FROM FDA
TEMECULA, CA 92589
DEVICE: OMNILINK .035 BILIARY STENT SYSTEM
GUIDANT CORP. 510(k) NO: K011506(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 408-845-1419
3200 LAKESIDE DR. SE DECISION MADE: 15-JUN-01
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
HARDY DIAGNOSTICS 510(k) NO: K011384(TRADITIONAL)
ATTN: MELISSA M TRAYLOR, RAC PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 13-JUN-01
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
HEADSTAR MEDICAL PRODUCTS CO., LTD510(k) NO: K002846(TRADITIONAL)
ATTN: PHONE NO :
NO 23, LANE 431, HWA CHEN RD SE DECISION MADE: 06-JUN-01
HSIN-CHUANG CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA ROC 242
DEVICE: POWDER-FREE VINYL EXAM GLOVE, YELLOW
HEYUAN HONGLI INDUSTRIES, INC. 510(k) NO: K011413(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 05-JUN-01
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINAL EXAM GLOVES
HEYUAN HONGLI INDUSTRIES, INC. 510(k) NO: K011414(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 05-JUN-01
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
HMT, INC. 510(k) NO: K011435(TRADITIONAL)
ATTN: SEUNG K MO PHONE NO : 011 822 34617235
3/4 FL. HAK BLDG. 249-13 SE DECISION MADE: 22-JUN-01
YANGJAE-DONG, SEOCHO-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 137-130 THIRD PARTY REVIEW
DEVICE: TEMP-A-SURE
HOMECARE TECHNOLOGIES LTD. 510(k) NO: K010866(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 2 9932768
POB 6718 SE DECISION MADE: 06-JUN-01
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMMED OBSERVER, MODEL I
HOMMED LLC. 510(k) NO: K003180(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DRIVE SE DECISION MADE: 28-JUN-01
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 HUMERAL NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K011529(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 12-JUN-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE
HOWMEDICA OSTEONICS CORP. 510(k) NO: K011622(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 15-JUN-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXETER HIP SYSTEM WITH V40 TAPER
HOWMEDICA OSTEONICS CORP. 510(k) NO: K011623(SPECIAL)
ATTN: NANCY J RIEDER PHONE NO : 201-934-4364
59 ROUTE 17 SE DECISION MADE: 15-JUN-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO CR SUPERFLEX TIBIAL INSERT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K011643(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 28-JUN-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR
HUDSON RESPIRATORY CARE, INC. 510(k) NO: K011125(TRADITIONAL)
ATTN: JEANNIE L DENNING PHONE NO : 909-676-5611
27711 DIAZ RD. SE DECISION MADE: 13-JUN-01
P.O. BOX 9020 510(k) SUMMARY AVAILABLE FROM FDA
TEMECULA, CA 92589-9020
DEVICE: OXYGEN SUPPLY TUBING, MODEL 1115
HUDSON RESPIRATORY CARE, INC. 510(k) NO: K011134(TRADITIONAL)
ATTN: JEANNIE K DENNING PHONE NO : 909-676-5611
27711 DIAZ RD. SE DECISION MADE: 13-JUN-01
P.O. BOX 9020 510(k) SUMMARY AVAILABLE FROM FDA
TEMECULA, CA 92589-9020
DEVICE: HYCARE LATEX EXAMINATION GLOVE, POWDERED
HYCARE INTL. CO., LTD. 510(k) NO: K010875(TRADITIONAL)
ATTN: JOHN GRASSI PHONE NO : 954-418-0887
1001 SE 12TH TERRACE SE DECISION MADE: 07-JUN-01
DEERFIELD BEACH, FL 33441 510(k) STATEMENT
DEVICE: MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
HYDROCISION, INC. 510(k) NO: K011612(SPECIAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893
7 TIFFANY TRAIL SE DECISION MADE: 22-JUN-01
HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICS MEDICAL CHARTR OAE WITH TYMP
ICS MEDICAL CORP. 510(k) NO: K011181(TRADITIONAL)
ATTN: DELMAR F BLOEM PHONE NO : 800-289-2150
125 COMMERCE DR. SE DECISION MADE: 25-JUN-01
SCHAUMBURG, IL 60173-5329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCELLECT
IMTEC CORP. 510(k) NO: K010775(TRADITIONAL)
ATTN: M.K. PATTERSON PHONE NO : 405-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 12-JUN-01
ARDMORE, OK 73401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTI-ICP MONITORING SYSTEM
INNERSPACE, INC. 510(k) NO: K003905(TRADITIONAL)
ATTN: DONALD E BOBO PHONE NO : 949-752-8672
2933 SOUTH PULLMAN ST., SE DECISION MADE: 15-JUN-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705
DEVICE: ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
INNERSPACE, INC. 510(k) NO: K010422(TRADITIONAL)
ATTN: DONALD E BOBO PHONE NO : 949-752-8672
2933 SOUTH PULLMAN ST., SE DECISION MADE: 28-JUN-01
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705
DEVICE: MALE NATURAL RUBBER LATEX CONDOM
INNOLATEX SDN. BHD 510(k) NO: K010919(ABBREVIATED)
ATTN: CHANG AH-KAU PHONE NO : 603 747 2434
NO 16, JALAN BULAN U5/5 SE DECISION MADE: 15-JUN-01
BANDAR PINGGIRAN SUBANG, 510(k) STATEMENT
SHAH ALAM,SELANGOR DARUL EHSAN, MALAYSIA
DEVICE: HEARTCARD, MODEL 5258
INSTROMEDIX 510(k) NO: K010945(TRADITIONAL)
ATTN: ALDEN KAY PHONE NO : 858-777-2200
6779 MESA RIDGE RD., SUITE 200 SE DECISION MADE: 12-JUN-01
SAN DIEGO, CA 92121-2909 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IL TEST PROS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K011424(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 25-JUN-01
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROGEN NERVE GUIDE
INTEGRA LIFESCIENCES CORP. 510(k) NO: K011168(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-275-0500
105 MORGAN LN. SE DECISION MADE: 22-JUN-01
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K010193(TRADITIONAL)
ATTN: JOHN CLAY PHONE NO : 732-548-5700
23 NEVSKY ST. SE DECISION MADE: 06-JUN-01
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACONCENTRATOR SYSTEM
INTERPORE CROSS INTL. 510(k) NO: K011148(SPECIAL)
ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 13-JUN-01
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
INTERPORE CROSS INTL. 510(k) NO: K011437(SPECIAL)
ATTN: LYNN RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 06-JUN-01
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDUO BLOOD GLUCOSE METER
INVERNESS MEDICAL TECHNOLOGY, INC.510(k) NO: K011616(SPECIAL)
ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900
51 SAWYER ROAD SE DECISION MADE: 21-JUN-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02453-3448
DEVICE: MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
IODP SA 510(k) NO: K011095(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 13-JUN-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81
IRVINE BIOMEDICAL, INC. 510(k) NO: K010471(SPECIAL)
ATTN: JAMES FARNWORTH PHONE NO : 949-851-3053
2146-A MICHELSON DR. SE DECISION MADE: 06-JUN-01
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K011598(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 13-JUN-01
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISCREEN VISION SCREENER
ISCREEN, LLC. 510(k) NO: K010315(TRADITIONAL)
ATTN: PETER THRALL PHONE NO : 901-888-0071
668 COLONIAL RD. (SUITE 1) SE DECISION MADE: 01-JUN-01
MEMPHIS, TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISLAND WOUND DRESSING WITH MICROBAN
ISLAND DRESSING, LLC. 510(k) NO: K010951(TRADITIONAL)
ATTN: JOHN A DOBOS PHONE NO : 716-874-1826
300 CORPORATE PARKWAY SE DECISION MADE: 11-JUN-01
SUITE 116N 510(k) STATEMENT
AMHERST, NY 14226
DEVICE: MODIFICATION TO EXCITE
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K011490(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 27-JUN-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: QUELL DESENSITIZER
JENERIC/PENTRON, INC. 510(k) NO: K010957(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 25-JUN-01
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: JP CAST 50
JENERIC/PENTRON, INC. 510(k) NO: K011330(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-JUN-01
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: JP CAST 40
JENERIC/PENTRON, INC. 510(k) NO: K011331(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 22-JUN-01
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: JMS A.V. FISTULA NEEDLE SET "WING EATER", MODEL 14G-18G
JMS CO., LTD. 510(k) NO: K010406(TRADITIONAL)
ATTN: KEISUKE URATOMI PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 20-JUN-01
HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT
DEVICE: JMS APHERESIS NEEDLE "WING EATER", MODEL 14G-18G
JMS CO., LTD. 510(k) NO: K010410(TRADITIONAL)
ATTN: KEISUKE URATOMI PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 20-JUN-01
HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT
DEVICE: FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODE
JOMED AG 510(k) NO: K010838(TRADITIONAL)
ATTN: GLENN BYRD PHONE NO : 301-998-6151
1700 ROCKVILLE PIKE, SUITE 400 SE DECISION MADE: 21-JUN-01
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA MINIATURE TELESCOPE AND ACCESSORIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K010987(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 19-JUN-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO KSEA ENDOTIP SYSTEM
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K011359(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 28-JUN-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEYST0NE MEDICAL PICC CATHETER
KEYSTONE MEDICAL 510(k) NO: K011860(TRADITIONAL)
ATTN: ALAN P SCHWARTZ PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 27-JUN-01
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZURICH DISTRACTION SYSTEM
KLS-MARTIN L.P. 510(k) NO: K010139(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 29-JUN-01
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
LANGHAM OPHTHALMIC TECHNOLOGIES 510(k) NO: K010998(TRADITIONAL)
ATTN: MAURICE E LANGHAM PHONE NO : 410-252-9924
9 CANDLELIGHT COURT SE DECISION MADE: 27-JUN-01
TIMONIUM, MD 21093 510(k) STATEMENT
DEVICE: TDP CQ-27 HEAT LAMP
LHASA MEDICAL, INC. 510(k) NO: K003538(TRADITIONAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1071
234 LIBBEY PKWY. SE DECISION MADE: 04-JUN-01
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSECO HEMODYNAMIC MONITOR CM71
LIDCO LTD. 510(k) NO: K010049(TRADITIONAL)
ATTN: GREGORY SPELLER PHONE NO : 440 020 72561006
16 ORSMAN RD. SE DECISION MADE: 14-JUN-01
LONDON, N15QJ, UNITED KINGDOM N15Q510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNAPADS
LUNAPADS INTERNATIONAL PRODUCTS LT510(k) NO: K010986(TRADITIONAL)
ATTN: SUZANNE SIEMENS PHONE NO : 604 681 9953
207 WEST 6TH AVENUE SE DECISION MADE: 13-JUN-01
VANCOUVER BC, CANADA V5Y 1K7 510(k) STATEMENT
DEVICE: PARADIGM QUICK-SET INFUSION SET
MAERSK MEDICAL A/S 510(k) NO: K011071(TRADITIONAL)
ATTN: GERDA RESCH PHONE NO : 818-576-4198
18000 DEVONSHIRE STREET SE DECISION MADE: 07-JUN-01
NORTHRIDGE, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC VIEW, MODEL 2001
MAGNA LAB, INC. 510(k) NO: K010802(TRADITIONAL)
ATTN: LYNN CARTER PHONE NO : 617-964-9100
150 CALIFORNIA STREET SE DECISION MADE: 08-JUN-01
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANAN SPRITACRE SPINAL NEEDLES
MANAN MEDICAL PRODUCTS, INC. 510(k) NO: K011209(TRADITIONAL)
ATTN: ROBBIE PALADUGU PHONE NO : 847-637-3333
241 W. PALATINE ROAD SE DECISION MADE: 26-JUN-01
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: MAR COR SERVICES BICARB SYSTEM
MAR COR SERVICES, INC. 510(k) NO: K003560(TRADITIONAL)
ATTN: MICHAEL ROBERTSON PHONE NO : 215-256-9585
364 MAPLE AVE. SE DECISION MADE: 08-JUN-01
HARLEYSVILLE, PA 19438 510(k) STATEMENT
DEVICE: MAR COR SERVICES SEMPER PURE RO MACHINE
MAR COR SERVICES, INC. 510(k) NO: K003877(ABBREVIATED)
ATTN: ANDREW G STITZINGER PHONE NO : 215-256-9585
364 MAPLE AVE. SE DECISION MADE: 22-JUN-01
HARLEYSVILLE, PA 19438 510(k) STATEMENT
DEVICE: MX8000 V5.0 CT SYSTEM
MARCONI MEDICAL SYSTEMS 510(k) NO: K010817(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER RD. SE DECISION MADE: 15-JUN-01
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THIN FILM DRESSING FOR ULTRASOUND EXAM
MARTIN E. WENDELKEN 510(k) NO: K011284(TRADITIONAL)
ATTN: MARTIN E WENDELKEN PHONE NO : 718-542-0472
610 BOULEVARD SE DECISION MADE: 20-JUN-01
ELMWOOD PARK, NJ 07407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
MDS NORDION, INC. 510(k) NO: K010682(TRADITIONAL)
ATTN: E.S. MARTELL PHONE NO : 613 592 3400
447 MARCH RD. SE DECISION MADE: 05-JUN-01
KANATA, ONTARIO, CANADA K2K1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ML BLADE, MODEL ML7030
MED-LOGICS, INC. 510(k) NO: K010872(TRADITIONAL)
ATTN: GARY MOCNIK PHONE NO : 949-363-2953
27881 LA PAZ #G316 SE DECISION MADE: 22-JUN-01
LAGUNA NIGUEL,, CA 92677 510(k) STATEMENT
DEVICE: UNI-LASER 470
MEDART CORP. 510(k) NO: K010885(TRADITIONAL)
ATTN: JAN K ENEMAERKE PHONE NO : 858-350-1106
11772 SORRENTO VALLEY RD. SE DECISION MADE: 07-JUN-01
SUITE #240 510(k) STATEMENT
SAN DIEGO, CA 92121
DEVICE: CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K011548(TRADITIONAL)
ATTN: DARWIN RICHARDSON PHONE NO : 805-987-7891
5300 ADOLFO ROAD SE DECISION MADE: 18-JUN-01
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K010927(TRADITIONAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
216 W. COURT STREET # 47 SE DECISION MADE: 19-JUN-01
WOODLAND, CA 95695 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLITE VL PULSED LIGHT SYSTEM
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K010928(TRADITIONAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
216 W. COURT STREET # 47 SE DECISION MADE: 19-JUN-01
WOODLAND, CA 95695 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
MEDICAL CABLES, INC. 510(k) NO: K010920(TRADITIONAL)
ATTN: ROBERT HILMAN PHONE NO : 800-828-1599
1340 LOGAN AVE. SE DECISION MADE: 22-JUN-01
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP ULTRA-FLOW CATHETER
MEDICAL COMPONENTS, INC. 510(k) NO: K003207(TRADITIONAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 12-JUN-01
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP ASH SPLIT
MEDICAL COMPONENTS, INC. 510(k) NO: K011576(SPECIAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 21-JUN-01
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BPFONE, MODEL UA 767IT
MEDICAL MONITORS PTY LIMITED 510(k) NO: K010751(ABBREVIATED)
ATTN: HARRY L PLATT PHONE NO : 612 931 00300
166 BELMORE ROAD; SUITE 14 SE DECISION MADE: 11-JUN-01
RANDWICK NSW, AUSTRALIA 2031 510(k) STATEMENT
DEVICE: PORTABLE INSTENSIVE CARE UNIT
MEDICAL RESEARCH LABORATORIES, INC510(k) NO: K010207(SPECIAL)
ATTN: JOEL ORLINSKY PHONE NO : 847-520-0300
1000 ASBURY DRIVE SE DECISION MADE: 14-JUN-01
BUFFALO GROVE, IL 60089 510(k) STATEMENT
DEVICE: SIDEPORT PINCH CLAMP DEVICE
MEDIVICE SYSTEMS, LTD. 510(k) NO: K010888(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 27-JUN-01
20 HATA'AS ST. 510(k) STATEMENT
KFAR SABA, ISRAEL 44425
DEVICE: REW-Q-KIT, RES-Q-MASK AND RES-Q-PAD
MEDTEQ INNOVATIONS PTY LTD 510(k) NO: K003937(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-838-3120
7361 CALHOUN PLACE, SUITE 500 SE DECISION MADE: 06-JUN-01
ROCKVILLE, MD 20855-2765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERDICT -II METHAMPHETAMINE
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K010226(TRADITIONAL)
ATTN: LARRY R PILOT PHONE NO : 202-496-7500
1238 ANTHONY RD. SE DECISION MADE: 01-JUN-01
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: VERDICT -II TCA, VERDICT-II MTD
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K011545(SPECIAL)
ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 08-JUN-01
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VO
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K010701(TRADITIONAL)
ATTN: RIHCARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-JUN-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K010181(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-344-0807
1800 PYRAMID PL. SE DECISION MADE: 12-JUN-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K011029(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 05-JUN-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K011508(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 12-JUN-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALM
MEDTRONIC XOMED, INC. 510(k) NO: K011191(TRADITIONAL)
ATTN: DIANA TAYLOR PHONE NO : 904-332-8959
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 26-JUN-01
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO XPS 3000 SYSTEM
MEDTRONIC XOMED, INC. 510(k) NO: K011321(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 26-JUN-01
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATI
MEDTRONIC, INC. 510(k) NO: K011584(TRADITIONAL)
ATTN: DAVID H MUELLER PHONE NO : 763-514-5633
800 53RD AVENUE, N.E. SE DECISION MADE: 22-JUN-01
MINNEAPOLIS,, MN 55421 510(k) STATEMENT
DEVICE: MERIDIAN-PORTABLE
MERIDIAN CO., LTD. 510(k) NO: K010897(TRADITIONAL)
ATTN: SOO-RANG LEE PHONE NO : 822 219 43320
3F MEDISON VENTURE TOWER SE DECISION MADE: 19-JUN-01
997-4 DAECHI-DONG 510(k) SUMMARY AVAILABLE FROM FDA
KANGNAM-KU; SEOUL, REPUBLIC OF KOREA
DEVICE: FAST THERMOMETER MODELS ST713C AND ST713F
MESURE TECHNOLOGY 510(k) NO: K011585(TRADITIONAL)
ATTN: PHIL ZULUETA PHONE NO : 818-354-1566
P.O. BOX 2249 SE DECISION MADE: 13-JUN-01
MISSION VIEJO, CA 92690 510(k) STATEMENT
DEVICE: MULTI-STIM, MODEL MS-100
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K001897(TRADITIONAL)
ATTN: ROB HOPKINS PHONE NO : 61 397 751234
57 ASTER AVE. SE DECISION MADE: 12-JUN-01
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 1
MICRO THERAPEUTICS, INC. 510(k) NO: K011526(SPECIAL)
ATTN: EBEN GORDON PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 14-JUN-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 10
MICRO THERAPEUTICS, INC. 510(k) NO: K011656(SPECIAL)
ATTN: EBEN GORDON PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 20-JUN-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRIDAU OPIATE ASSAY
MICROGENICS CORP. 510(k) NO: K011150(TRADITIONAL)
ATTN: SHERRIE RINNE PHONE NO : 510-979-5150
46360 FREMONT BLVD. SE DECISION MADE: 20-JUN-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H-SCRIBE
MORTARA INSTRUMENT, INC. 510(k) NO: K004017(TRADITIONAL)
ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 11-JUN-01
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MM-87 MOTOR-DRIVE MANIPULATOR
NARISHIGE CO., LTD. 510(k) NO: K011420(TRADITIONAL)
ATTN: MITSUKO YONEYAMA PHONE NO : 813 308 8383
27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 12-JUN-01
SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EN BLOC BIOPSY SYSTEM
NEOTHERMIA CORP. 510(k) NO: K003190(TRADITIONAL)
ATTN: SHERRIE COVAL-GOLDMSITH PHONE NO : 508-655-7820
ONE APPLE HILL SE DECISION MADE: 11-JUN-01
SUITE 316 510(k) SUMMARY AVAILABLE FROM FDA
NATICK, MA 01760
DEVICE: HANDMASTER
NEUROMUSCLAR ELECTRICAL STIMULATIO510(k) NO: K010837(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 15-JUN-01
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE BOLD SCREW
NEWDEAL S.A. 510(k) NO: K011262(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 15-JUN-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: READYSWIM
NIDACON INTERNATIONAL AB 510(k) NO: K011346(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 28-JUN-01
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPACK MICRO, MODEL MED-9100A SERIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K010590(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 28-JUN-01
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE NIMBLE ROCKET POWERED WHEELCHAIR
NIMBLE, INC. 510(k) NO: K010941(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 22-JUN-01
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 10121
DEVICE: NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
NIPRO MEDICAL CORP. 510(k) NO: K011297(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 20-JUN-01
LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPA EAR THERMOMETER MODEL # TD402
NORM PACIFIC AUTOMATION CORP. 510(k) NO: K011704(SPECIAL)
ATTN: CHI-CHU WU CHEN PHONE NO : 886 357 85853
3F, NO. 31, HU-PIN ROAD #1 SE DECISION MADE: 27-JUN-01
SBIP 510(k) STATEMENT
HSIN-CHU, CHINA (TAIWAN)
DEVICE: SILICONE IMPRESSION MATERIAL
NORTHEAST RESINS & SILICONES, LLC.510(k) NO: K011450(TRADITIONAL)
ATTN: SIVANANDA S JADA PHONE NO : 203-272-4931
698 ANDREA CT. SE DECISION MADE: 13-JUN-01
CHESHIRE, CT 06410 510(k) STATEMENT
DEVICE: NTERO NOMAD SYSTEM
NTERO SURGICAL, INC. 510(k) NO: K010815(TRADITIONAL)
ATTN: D. BOMMI BOMMANNNAN PHONE NO : 650-428-1000
1137D SAN ANTONIO ROAD SE DECISION MADE: 15-JUN-01
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NTI TENSION SUPPRESSION SYSTEM
NTI-TSS, INC. 510(k) NO: K010876(TRADITIONAL)
ATTN: BOB WEBER PHONE NO : 219-258-5963
2303 BLUE SMOKE TRAIL SE DECISION MADE: 20-JUN-01
MISHAWAKA, IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC AS
OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K011577(TRADITIONAL)
ATTN: CHARLES R VERMETTE PHONE NO : 510-724-0384
629 TENNENT AVE. SE DECISION MADE: 19-JUN-01
PINOLE, CA 94564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSULIN PEN NEEDLE ADAPTER
OHANA NEEDLE CO. 510(k) NO: K010887(TRADITIONAL)
ATTN: SPENCER H OWADES PHONE NO : 978-470-0256
64 CHEEVER CIRCLE SE DECISION MADE: 08-JUN-01
ANDOVER, MA 01810-1727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
OLYMPUS AMERICA, INC. 510(k) NO: K011720(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LANE SE DECISION MADE: 25-JUN-01
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE,
ORASURE TECHNOLOGIES, INC. 510(k) NO: K011057(TRADITIONAL)
ATTN: R.SAM NIEDBALA PHONE NO : 610-882-1820
150 WEBSTER ST. SE DECISION MADE: 06-JUN-01
BETHLEHEM, PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTADERM WOUND DRESSING
ORGANOGENESIS, INC. 510(k) NO: K011026(TRADITIONAL)
ATTN: PATRICK R BILBO PHONE NO : 781-401-1155
150 DAN RD. SE DECISION MADE: 13-JUN-01
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIGEN DUAL LUMEN CATHETER
ORIGEN BIOMEDICAL, INC. 510(k) NO: K003288(TRADITIONAL)
ATTN: RICHARD MARTIN PHONE NO : 512-474-7278
2525 HARTFORD RD. SE DECISION MADE: 08-JUN-01
AUSTIN, TX 78703-2428 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K011463(SPECIAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 716-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 13-JUN-01
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K011250(TRADITIONAL)
ATTN: ANN QUINN PHONE NO : 716-453-4152
100 INDIGO CREEK DRIVE SE DECISION MADE: 13-JUN-01
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTRES TOOTHBRUSH SANITIZER MODEL TB100W
OTRES, LLC. 510(k) NO: K003517(TRADITIONAL)
ATTN: DAVID BUDDINGH PHONE NO : 630-505-8025
4225 NAPERVILLE ROAD SE DECISION MADE: 06-JUN-01
SUITE 155 510(k) STATEMENT
LISLE, IL 60542
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES
P.T. HEALTHCARE GLOVINDO 510(k) NO: K010233(TRADITIONAL)
ATTN: ELLEN HUTAPEA PHONE NO : 620 616 850015
JL. KOL. YOS SUDARSO K.M. 10 SE DECISION MADE: 22-JUN-01
KAWASAN INDUSRI MEDAN (KIM) 510(k) STATEMENT
MEDAN 10340, INDONESIA 10340
DEVICE: SELF-ADHESIVE ELECTRODES
PAIN MANAGEMENT TECHNOLOGIES 510(k) NO: K011411(TRADITIONAL)
ATTN: JOSHUA LEFKOVITZ PHONE NO : 330-762-7474
43 E. MARKET ST. SE DECISION MADE: 13-JUN-01
AKRON, OH 44308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIVESURE AMPHETAMINE SCREEN TEST
PAN PROBE BIOTECH, INC. 510(k) NO: K011609(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 08-JUN-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIVESURE METHAMPHETAMINE SCREEN TESTS
PAN PROBE BIOTECH, INC. 510(k) NO: K011610(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 08-JUN-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KOKO PEAK KP; KOKO PEAK KP+
PDS HEALTHCARE PRODUCTS, INC. 510(k) NO: K010009(ABBREVIATED)
ATTN: CHERYL RAILSBACK PHONE NO : 303-666-6340
908 MAIN ST. SE DECISION MADE: 01-JUN-01
LOUISVILE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA DELTA
PENLON LTD. 510(k) NO: K002343(TRADITIONAL)
ATTN: ANTHONY PARSONS PHONE NO : 44 123 5547000
RADLEY ROAD SE DECISION MADE: 08-JUN-01
AINGDON 510(k) SUMMARY AVAILABLE FROM FDA
OXONN, UNITED KINGDOM OX14 3PH
DEVICE: PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
PERCUSURGE, INC. 510(k) NO: K003992(TRADITIONAL)
ATTN: MATTHEW J MOON PHONE NO : 408-530-2370
540 OAKMEAD PKWY. SE DECISION MADE: 01-JUN-01
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
PLANMECA OY 510(k) NO: K011619(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-953-2368
1250 GREENBRIAR SE DECISION MADE: 29-JUN-01
SUITE A 510(k) STATEMENT
ADDISON, IL 60111
DEVICE: BIOSCANNER CREATININE TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K010456(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 20-JUN-01
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAC PLUS NEEDLELESS ACCESS CONNECTOR
POREX MEDICAL PRODUCTS 510(k) NO: K011193(TRADITIONAL)
ATTN: TIM TRUITT PHONE NO : 909-390-9080
930 WANAMAKER SE DECISION MADE: 12-JUN-01
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: MEDPOR QUAD MOTILITY IMPLANT
POREX SURGICAL, INC. 510(k) NO: K010902(TRADITIONAL)
ATTN: HOWARD MERCER PHONE NO : 800-521-7321
15 DART RD. SE DECISION MADE: 19-JUN-01
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCEDURE MASKS: PM4-301 AND PM4-304
PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K011789(SPECIAL)
ATTN: KATHERINE CO PHONE NO : 780 497 7600EXT225
10707 100TH AVE., SUITE 300 SE DECISION MADE: 22-JUN-01
EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) STATEMENT
DEVICE: PROACT 1
PROACT CO. 510(k) NO: K003909(TRADITIONAL)
ATTN: JEAN ROZINT PHONE NO : 843-971-1414
PO BOX 1026 SE DECISION MADE: 13-JUN-01
MT PLEASANT, SC 29465-1026 510(k) STATEMENT
DEVICE: AUTOMATED CORE BIOPSY DEVICE
PROMEX, INC. 510(k) NO: K011270(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-736-0128
3049 HUDSON STREET SE DECISION MADE: 22-JUN-01
FRANKLIN, IN 46131 510(k) STATEMENT
DEVICE: CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
PROTECTION GLOVES SDN. BHD. 510(k) NO: K010854(TRADITIONAL)
ATTN: RICHARD CHOOI PHONE NO : 07 926 3909
LOT NO. 236, BATU 2 1/2, SE DECISION MADE: 13-JUN-01
JALAN YONG PENG 510(k) SUMMARY AVAILABLE FROM FDA
CHAAH, JOHOR, MALAYSIA 85400
DEVICE: CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
PROTECTION GLOVES SDN. BHD. 510(k) NO: K011231(TRADITIONAL)
ATTN: RICHARD CHOOI PHONE NO : 07 926 3909
LOT NO. 236, BATU 2 1/2, SE DECISION MADE: 13-JUN-01
JALAN YONG PENG 510(k) SUMMARY AVAILABLE FROM FDA
CHAAH, JOHOR, MALAYSIA 85400
DEVICE: PTW DOSIMETRY DIODE, T60008
PTW-NEW YORK CORP. 510(k) NO: K010916(TRADITIONAL)
ATTN: STEPHEN R SZEGLIN PHONE NO : 516-827-3181
201 PARK AVE. SE DECISION MADE: 20-JUN-01
HICKSVILLE, NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-RAD RADIOGRAPHIC SYSTEM
QUANTUM MEDICAL IMAGING, LLC. 510(k) NO: K011486(TRADITIONAL)
ATTN: MARK CAMIRAND PHONE NO : 631-567-5800
2905 VETERANS MEMORIAL HIGHWAY SE DECISION MADE: 20-JUN-01
RONKONKOMA, NY 11779 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XSCAN32 TELERADIOLOGY SOFTWARE
RADIOGRAPHIC DIGITAL IMAGING, INC.510(k) NO: K002911(TRADITIONAL)
ATTN: STEPHEN NEUSHUL PHONE NO : 310-639-4920
1215 SOUTH ALAMEDA ST. SE DECISION MADE: 07-JUN-01
COMPTON, CA 90220 510(k) STATEMENT
DEVICE: BIPAP PRO BI-LEVEL SYSTEM
RESPIRONICS, INC. 510(k) NO: K011714(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE SE DECISION MADE: 28-JUN-01
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
ROCHE DIAGNOSTICS CORP. 510(k) NO: K011145(TRADITIONAL)
ATTN: JENNIFER TRIBETT PHONE NO : 317-845-2000
9115 HAGUE RD. SE DECISION MADE: 25-JUN-01
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K011226(ABBREVIATED)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 25-JUN-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK ACTIVE SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K011738(SPECIAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 20-JUN-01
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: AMBULATORY ENTERAL NUTRITION PUMP
ROSS PRODUCT DIV. ABBOTT LABORATOR510(k) NO: K003047(TRADITIONAL)
ATTN: YUKA HENDERSHOT PHONE NO : 614-624-7068
625 CLEVELAND AVENUE SE DECISION MADE: 12-JUN-01
COLUMBUS, OH 43215-1724 510(k) STATEMENT
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW13
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K011523(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 14-JUN-01
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: HARD RELINER
S & C POLYMER GMBH 510(k) NO: K011277(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 49 412 18619
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 26-JUN-01
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESIN CEM
S & C POLYMER GMBH 510(k) NO: K011431(TRADITIONAL)
ATTN: CHRISTIAN BOTTCHER PHONE NO : 494 121 4830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 11-JUN-01
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMOACT ULTRASONIC NEBULIZER, MODEL 3060
SAN UP S.A. 510(k) NO: K002543(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NOTHERN BLVD., SUITE 200 SE DECISION MADE: 14-JUN-01
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
SANDHILL SCIENTIFIC, INC. 510(k) NO: K002427(ABBREVIATED)
ATTN: LIUNDA L DIEDERICH PHONE NO : 303-470-7020
9150 COMMERCE CENTER CIR.,#500 SE DECISION MADE: 22-JUN-01
HIGHLANDS RANCH, CO 80126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
SATELEC 510(k) NO: K011001(TRADITIONAL)
ATTN: JEAN-LUC BOULNOIS PHONE NO : 781-239-8108
70 WALNUT ST. SE DECISION MADE: 07-JUN-01
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
SCIENCE, INC. 510(k) NO: K010824(TRADITIONAL)
ATTN: LYNN S WEIST PHONE NO : 952-835-1333
MINNESOTA CENTER, SUITE 1060 SE DECISION MADE: 05-JUN-01
7760 FRANCE AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, MN 55435-5803
DEVICE: TPO IGG ANTIBODY EIA TEST
SCIMEDX CORP. 510(k) NO: K011082(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 973-625-8822
400 FORD RD. SE DECISION MADE: 06-JUN-01
DENVILLE, NJ 07834 510(k) STATEMENT
DEVICE: PHASE II GBM IGG ANTIBODY EIA TEST
SCIMEDX CORP. 510(k) NO: K011348(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 973-625-8822
400 FORD RD. SE DECISION MADE: 25-JUN-01
DENVILLE, NJ 07834 510(k) STATEMENT
DEVICE: HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HY
SEBIA 510(k) NO: K011113(TRADITIONAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WAERLOO ROAD SE DECISION MADE: 13-JUN-01
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
SEQUAL TECHNOLOGIES, INC. 510(k) NO: K003472(TRADITIONAL)
ATTN: RON HALL PHONE NO : 858-558-0202
11436 SORRENTO VALLEY RD. SE DECISION MADE: 04-JUN-01
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND
SGMP CO., LTD. 510(k) NO: K011370(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 07-JUN-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STE
SGMP CO., LTD. 510(k) NO: K011371(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 07-JUN-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND
SGMP CO., LTD. 510(k) NO: K011377(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 07-JUN-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
SIEMENS HEARING INSTRUMENTS, INC. 510(k) NO: K011364(TRADITIONAL)
ATTN: DAVE SLAVIN PHONE NO : 732-562-6658
10 CONSTITUTION AVE. SE DECISION MADE: 07-JUN-01
P.O. BOX 1397 510(k) SUMMARY AVAILABLE FROM FDA
PISCATAWAY, NJ 08855
DEVICE: CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
SIEMENS HEARING INSTRUMENTS, INC. 510(k) NO: K011366(TRADITIONAL)
ATTN: DAVE SLAVIN PHONE NO : 732-562-6658
10 CONSTITUTION AVE. SE DECISION MADE: 01-JUN-01
P.O. BOX 1397 510(k) SUMMARY AVAILABLE FROM FDA
PISCATAWAY, NJ 08855
DEVICE: SYNGO MULTIMODALITY WORKSTATION
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K010938(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4500
186 WOOD AVENUE SOUTH SE DECISION MADE: 26-JUN-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI ADVISOR VITAL SIGNS MONITOR (9200)
SIMS BCI, INC. 510(k) NO: K010770(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 12-JUN-01
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI 3403 SLEEP SCREENING PULSE OXIMETER
SIMS BCI, INC. 510(k) NO: K011156(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 14-JUN-01
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW RESTIM
SMITH & NEPHEW, INC. 510(k) NO: K003596(TRADITIONAL)
ATTN: CORDELL C HOFFINS PHONE NO : 262-253-3069
N104 W13400 DONGES BAY RD. SE DECISION MADE: 06-JUN-01
GERMANTOWN, WI 53022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
SMITH & NEPHEW, INC. 510(k) NO: K011299(TRADITIONAL)
ATTN: TIM CRABTREE PHONE NO : 978-749-1068
160 DASCOMB RD. SE DECISION MADE: 27-JUN-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE
SPACELABS MEDICAL, INC. 510(k) NO: K003663(TRADITIONAL)
ATTN: IRENE JAWORSKI PHONE NO : 425-882-3913
15220 N.E. 40TH ST. SE DECISION MADE: 28-JUN-01
P.O. BOX 97013 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073-9713
DEVICE: SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR
SPECIALTY ULTRAVISION, INC. 510(k) NO: K011542(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 408-341-0700
307 ORCHARD CITY DR. SE DECISION MADE: 26-JUN-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CAMPBELL, CA 95008
DEVICE: THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
SPINTECH, INC. 510(k) NO: K010692(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET NW SUITE 700 SE DECISION MADE: 29-JUN-01
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
STANDARD TEXTILE CO., INC. 510(k) NO: K010799(TRADITIONAL)
ATTN: BRADLEY J BUSCHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 07-JUN-01
P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45237-1600
DEVICE: SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIG
STERLING MEDIVATIONS, INC. 510(k) NO: K011187(ABBREVIATED)
ATTN: JOEL DOUGLAS PHONE NO : 952-473-7971
180 FERNDALE ROAD SOUTH SE DECISION MADE: 19-JUN-01
WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY SOFT QD SILVER INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K011580(SPECIAL)
ATTN: JOEL S DOUGLAS PHONE NO : 952-473-7971
180 FERNDALE ROAD SOUTH SE DECISION MADE: 05-JUN-01
WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURO-TRAIN III (3)
STERNE EQUIPMENT CO., LTD. 510(k) NO: K003433(TRADITIONAL)
ATTN: THOMAS WALLACE PHONE NO : 905 457 2524
7 RESEARCH RD. SE DECISION MADE: 15-JUN-01
BRAMPTON, ON., CANADA L6W 1P4 510(k) STATEMENT
DEVICE: STIMUPLEX HNS-11
STOCKERT GMBH 510(k) NO: K003983(TRADITIONAL)
ATTN: DOMINIKA SCHULER PHONE NO : 497 612 07160
BOTZINGER STRABE 72 SE DECISION MADE: 06-JUN-01
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARA 5X
STRECK LABORATORIES, INC. 510(k) NO: K011410(TRADITIONAL)
ATTN: PAUL KETTELSON PHONE NO : 402-537-5312
7002 SOUTH 109TH ST. SE DECISION MADE: 26-JUN-01
LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 HYTREL (R) TOGAS
STRYKER CORP. 510(k) NO: K011755(SPECIAL)
ATTN: SUZANNE VELASQUEZ PHONE NO : 616-323-7700
4100 E. MILHAM AVE. SE DECISION MADE: 22-JUN-01
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: STRYKER PAINPUMP PCA
STRYKER INSTRUMENTS 510(k) NO: K003543(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 05-JUN-01
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
SULZER DENTAL, INC. 510(k) NO: K011245(TRADITIONAL)
ATTN: FOSTER BOOP PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 25-JUN-01
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QED DIODE DETECTORS, MODELS 1112-1116
SUN NUCLEAR CORP. 510(k) NO: K011466(SPECIAL)
ATTN: JIM MIXON PHONE NO : 321-259-6862
425-A PINEDA COURT SE DECISION MADE: 06-JUN-01
MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLT LASERPRO CTH HOLMIUM LASER SYSTEM
SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K011409(TRADITIONAL)
ATTN: DAVIS WOODWARD PHONE NO : 215-619-3278
147 KEYSTONE DR. SE DECISION MADE: 14-JUN-01
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SEALAPEX 4
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K010940(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 20-JUN-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USS-LINE EXTENSION
SYNTHES 510(k) NO: K010108(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-JUN-01
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1262
DEVICE: MODIFIED USS FRACTURE SYSTEM
SYNTHES (USA) 510(k) NO: K010658(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 04-JUN-01
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYS
SYNTHES (USA) 510(k) NO: K010766(TRADITIONAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 12-JUN-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES STERNAL FIXATION SYSTEM
SYNTHES (USA) 510(k) NO: K010943(ABBREVIATED)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 27-JUN-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
SYNTHES (USA) 510(k) NO: K011034(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 27-JUN-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
SYVA CO. 510(k) NO: K011528(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
3403 YERBA BUENA ROAD SE DECISION MADE: 06-JUN-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
SYVA CO., DADE BEHRING, INC. 510(k) NO: K011605(SPECIAL)
ATTN: SUSAN COLLINS PHONE NO : 408-239-4412
3404 YERBA BUENA ROAD SE DECISION MADE: 12-JUN-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
SYVA CO., DADE BEHRING, INC. 510(k) NO: K011620(SPECIAL)
ATTN: CYNTHIA ARREDONDO PHONE NO : 408-239-2671
3403 YERBA BUENA ROAD SE DECISION MADE: 18-JUN-01
SAN JOSE, CA 95135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
TAIWAN ARMADA ENTERPRISE CO., LTD.510(k) NO: K011701(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 22-JUN-01
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: TAUT BALLOON CATHETER, MODEL 50640
TAUT, INC. 510(k) NO: K011018(TRADITIONAL)
ATTN: RON KENSETH PHONE NO : 630-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 22-JUN-01
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: SPINAL EPIDURAL NEEDLES
TE ME NA S.A.R.L. 510(k) NO: K002405(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 01-JUN-01
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBD-CHEK
TECHLAB, INC. 510(k) NO: K011396(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
1861 PRATT DR., STE. 1030 SE DECISION MADE: 18-JUN-01
BLACKSBURG, VA 24060-6364 510(k) STATEMENT
DEVICE: COCAINE DIPSTICK TEST, MODEL D747-A
TECO DIAGNOSTICS 510(k) NO: K010239(TRADITIONAL)
ATTN: DINDO CARRILLO PHONE NO : 714-693-7788
4925 EAST HUNTER AVE. SE DECISION MADE: 25-JUN-01
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: MEMODYN STAPLE
TELOS MEDICAL EQUIPMENT 510(k) NO: K002695(TRADITIONAL)
ATTN: AL E AUSTIN PHONE NO : 410-877-3029
1109 STURBRIDGE ROAD SE DECISION MADE: 13-JUN-01
FALLSTON, MD 21047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
THURIS CORP. 510(k) NO: K010669(TRADITIONAL)
ATTN: GRACE BARTOO PHONE NO : 650-654-4484
110 GLENN WAY # 6 SE DECISION MADE: 04-JUN-01
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER TOTAL ELBOW PROSTHESIS
TORNIER S.A. 510(k) NO: K011567(SPECIAL)
ATTN: IRENE GOSSET PHONE NO : 003 347 6613500
ZIRST-161, RUE LAVOISIER SE DECISION MADE: 19-JUN-01
MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TBW
TRI-MED, INC. 510(k) NO: K010545(TRADITIONAL)
ATTN: ROBERT J MEDOFF PHONE NO : 808-261-4658
159 KU'UKAMA ST. SE DECISION MADE: 06-JUN-01
KAILUA,, HI 96734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
TRUMPF MEDICAL SYSTEMS, INC. 510(k) NO: K011693(TRADITIONAL)
ATTN: WILLIAM APPERSON PHONE NO : 843-534-0606
415 JESSEN LANE SE DECISION MADE: 13-JUN-01
WANDO, SC 29492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROT
U.O.P. RUBBER PRODUCTS SDN BHD 510(k) NO: K011563(TRADITIONAL)
ATTN: CHUA BENG CHUAN PHONE NO : 04 593 1121
878 JALAN BANDAR BARU, NIBONG SE DECISION MADE: 05-JUN-01
TEBAL 510(k) STATEMENT
PENANG, MALAYSIA 14300
DEVICE: RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PER
VASCULAR INTERVENTION 510(k) NO: K011464(SPECIAL)
ATTN: JENNIFER PAE RIGGS PHONE NO : 909-914-4581
26531 YNEZ ROAD SE DECISION MADE: 13-JUN-01
TEMECULA, CA 92591-0339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/
W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K011061(TRADITIONAL)
ATTN: HERBERT TRASCHWANDTNER PHONE NO : 011 436 27462360
53 IGNAZ-GLAZER-STRASSE SE DECISION MADE: 28-JUN-01
BUERMOOS, AUSTRIA 5111 510(k) STATEMENT
DEVICE: WAKO AUTOKIT C4
WAKO CHEMICALS, USA, INC. 510(k) NO: K010325(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 25-JUN-01
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO AUTOKIT C3
WAKO CHEMICALS, USA, INC. 510(k) NO: K010326(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 25-JUN-01
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO LIPID CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K010334(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 25-JUN-01
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
WELCH ALLYN, INC. 510(k) NO: K010186(ABBREVIATED)
ATTN: DAVID A YOUNG II PHONE NO : 828-684-4895
95 OLD SHOALS RD. SE DECISION MADE: 08-JUN-01
ARDEN, NC 28704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YOUNG-HEALTH SUPER EAR THERMOMETER
YOUNG HEALTH IND. CO., LTD. 510(k) NO: K002727(TRADITIONAL)
ATTN: YANG RONK-JEH PHONE NO : 886 332 50866
N0.7 NANKANN SHIAH, LU-CHU SE DECISION MADE: 13-JUN-01
SHIANG 510(k) SUMMARY AVAILABLE FROM FDA
TAOYUAN HSIEN, CHINA (TAIWAN) 338
DEVICE: ZIEHM VISION
ZIEHM INTERNATIONAL, INC. 510(k) NO: K011292(TRADITIONAL)
ATTN: LANELL SAMANIEGO PHONE NO : 909-781-2020
4181 LATHAM ST. SE DECISION MADE: 20-JUN-01
RIVERSIDE, CA 92501 510(k) STATEMENT
DEVICE: EMBOGOLD MICROSPHERE
BIOSPHERE MEDICA, INC. 510(k) NO: K010026 (SPECIAL)
ATTN: JOHN D. BONASERA PHONE NO : 781-681-7900
1050 HINGHAM STREET SE DECISION MADE: 21-JUN-01
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 330
TOTAL WITH SUMMARIES 259
TOTAL WITH STATEMENTS 71
Updated 10/9/2001
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