SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUN-2006 THROUGH 30-JUN-2006
DEVICE: P.D
.DECIMAL, INC. 510(k) NO: K061440(TRADITIONAL)
ATTN: DANIEL BENNETT PHONE NO : 407-330-3300
121 CENTRAL PARK PLACE SE DECISION MADE: 27-JUN-06
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M LIQUID BANDAGE
3M COMPANY 510(k) NO: K053409(TRADITIONAL)
ATTN: BRYAN BECKER PHONE NO : 651-733-3373
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 19-JUN-06
ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
A & D ENGINEERING, INC. 510(k) NO: K061456(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113
1555 MCCANDLESS DR. SE DECISION MADE: 21-JUN-06
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY X-TRAC SYSTEM
A. TITAN INSTRUMENTS, INC. 510(k) NO: K060691(TRADITIONAL)
ATTN: MICHAEL TUBER PHONE NO : 716-648-9272
97 MAIN ST. SE DECISION MADE: 12-JUN-06
HAMBURG, NY 14075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT AXSYM TROPONIN-I ADV
ABBOTT LABORATORIES 510(k) NO: K060875(TRADITIONAL)
ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106
100 ABBOTT PARK ROAD SE DECISION MADE: 14-JUN-06
ABBOTT PARK, IL 60064-3500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXSYM DIGOXIN III
ABBOTT LABORATORIES 510(k) NO: K061249(SPECIAL)
ATTN: KENTON SMITH PHONE NO : 847-938-4807
D 9VA, BLDG. AP6C-2 SE DECISION MADE: 02-JUN-06
100 ABBOTT PARK RD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-3500
DEVICE: CREATININE
ABBOTT LABORATORIES INC 510(k) NO: K061193(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1921 HURD DRIVE SE DECISION MADE: 23-JUN-06
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCIN UNI-KNEE SYSTEM
ACCIN CORPORATION 510(k) NO: K060670(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832
1033 US HIGHWAY 46 EAST SE DECISION MADE: 02-JUN-06
SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA
CLIFTON, NJ 07013
DEVICE: ACELL POWDER WOUND DRESSING
ACELL, INC 510(k) NO: K060888(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVE. SE DECISION MADE: 23-JUN-06
SUITE 509 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET0
ACRO BIOTECH LLC. 510(k) NO: K053033(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749
9500 7TH STREET UNIT M SE DECISION MADE: 06-JUN-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG#
ACRO BIOTECH LLC. 510(k) NO: K053034(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749
9500 7TH STREET UNIT M SE DECISION MADE: 06-JUN-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
ACRO BIOTECH LLC. 510(k) NO: K053037(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749
9500 7TH STREET UNIT M SE DECISION MADE: 15-JUN-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT
DEVICE: ACUMEN SINGLE-LUMEN DELIVERY SHEATH
ACUMEN MEDICAL, INC. 510(k) NO: K053400(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 19-JUN-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUTE BONE SCREW
ACUTE INNOVATIONS LLC 510(k) NO: K061206(TRADITIONAL)
ATTN: ALYSSA THOMAS PHONE NO : 503-686-7200
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 19-JUN-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
HILLSBORO, OR 97124
DEVICE: CALSET COMPOSITE HEATER
ADDENT, INC. 510(k) NO: K061395(TRADITIONAL)
ATTN: JOSHUA FRIEDMAN PHONE NO : 203-778-0200
43 MIRY BROOK RD. SE DECISION MADE: 23-JUN-06
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART BRACHYTHERAPY APPLICATOR
ADVANCED RADIATION THERAPY, LLC 510(k) NO: K060299(TRADITIONAL)
ATTN: RAYMOND BRICAULT PHONE NO : 978-663-7300
9 LINNELL CIRCLE SE DECISION MADE: 06-JUN-06
BILLERICA, MA 01820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
ALARA, INC. 510(k) NO: K061538(SPECIAL)
ATTN: DIANE KING PHONE NO : 510-315-5173
47505 SEABRIDGE DRIVE SE DECISION MADE: 30-JUN-06
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDONE-COCAINE-150 TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K053422(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734
9110 RED BRANCH ROAD SE DECISION MADE: 15-JUN-06
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21045
DEVICE: AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
AMSINO INTERNATIONAL, INC. 510(k) NO: K061039(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888
855 TOWNE CENTER DR. SE DECISION MADE: 29-JUN-06
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K061178(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 12-JUN-06
QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANGER IRRIGATION FLUID WARMING SYSTEM
ARIZANT HEALTHCARE INC. 510(k) NO: K060939(TRADITIONAL)
ATTN: DAVID WESTLIN PHONE NO : 952-947-1277
10393 WEST 70TH ST. SE DECISION MADE: 26-JUN-06
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
ARTHROTEK, INC. 510(k) NO: K060693(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 574-372-1644
56 EAST BELL DR. SE DECISION MADE: 06-JUN-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
ASAHI INTECC CO., LTD. 510(k) NO: K060745(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 23-JUN-06
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLWOUND
AT SQUARED, LLC 510(k) NO: K053476(TRADITIONAL)
ATTN: JULIA C TIERNEY PHONE NO : 202-828-3427
1050 CONNECTICUT AVE., NW SE DECISION MADE: 26-JUN-06
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
ATLANTIS COMPONENTS, INC. 510(k) NO: K053373(TRADITIONAL)
ATTN: BETSY BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 30-JUN-06
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&L L-BETA, MODEL WL-B1
B&L BIOTECH CO., LTD. 510(k) NO: K060347(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 05-JUN-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIACAP ULTRA DIALYSIS FLUID FILTER
B. BRAUN MEDIZINTECHNOLOGIE GMBH 510(k) NO: K052764(TRADITIONAL)
ATTN: SCOTT J PEASE PHONE NO : 610-266-0500
901 MARCON BOULEVARD SE DECISION MADE: 09-JUN-06
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGI
BARRIERMED GLOVE CO. 510(k) NO: K061038(TRADITIONAL)
ATTN: VICTOR J RAGUCCI PHONE NO : 407-771-4424
155 TECHNOLOGY PARK SE DECISION MADE: 23-JUN-06
LAKE MARY, FL 32746 510(k) STATEMENT
DEVICE: SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED
BAUSCH & LOMB 510(k) NO: K061157(SPECIAL)
ATTN: DEBRA KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN ST. SE DECISION MADE: 22-JUN-06
ROCHESTER, NY 14609-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MO
BD BIOSCIENCES 510(k) NO: K060375(TRADITIONAL)
ATTN: CARTER NAVARRO PHONE NO : 408-432-9475
2350 QUME DR. SE DECISION MADE: 06-JUN-06
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
BECKMAN COULTER, INC. 510(k) NO: K061282(SPECIAL)
ATTN: JENNIFER RUETHER PHONE NO : 952-368-7629
1000 LAKE HAZELTINE DR. SE DECISION MADE: 02-JUN-06
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-3
BECTON, DICKINSON & CO. 510(k) NO: K061355(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 07-JUN-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLATELIA ASPERGILLUS EIA, MODEL 62793
BIO-RAD 510(k) NO: K060641(TRADITIONAL)
ATTN: CHRISTOPHER BENTSEN PHONE NO : 425-881-8300
CLINICAL DIAGNOSTICS GROUP SE DECISION MADE: 02-JUN-06
6565 185TH AVENUE NE 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052
DEVICE: THE DOUBLE GLOVE
BIOBARRIER, INC. 510(k) NO: K060030(TRADITIONAL)
ATTN: DAVID W MULLIS PHONE NO : 770-207-9174
367 PLEASANT VALLEY RD. SE DECISION MADE: 27-JUN-06
P.O. BOX 39 510(k) SUMMARY AVAILABLE FROM FDA
GOOD HOPE, GA 30641
DEVICE: MBCP GEL
BIOMATLANTE 510(k) NO: K060732(TRADITIONAL)
ATTN: MYRIAM VINCENT PHONE NO : 332 280 02009
5, RUE EDOUARD BELIN SE DECISION MADE: 02-JUN-06
VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSA-DIAL HUMERAL HEAD PROSTHESIS
BIOMET MANUFACTURING CORP. 510(k) NO: K060716(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 12-JUN-06
56. E. BELL DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: 36MM BIOLOX DELTA CERAMIC HEADS
BIOMET, INC. 510(k) NO: K061312(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 06-JUN-06
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596,
BIOPRO, INC. 510(k) NO: K061089(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 20-JUN-06
PORT HURON, MI 48060 510(k) STATEMENT
DEVICE: CARTO RMT EP NAVIGATION SYSTEM V8
BIOSENSE WEBSTER, INC. 510(k) NO: K060047(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 19-JUN-06
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE TOX DRUG SCREEN, MODEL 94400
BIOSITE INCORPORATED 510(k) NO: K060791(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 858-805-2821
9975 SUMMERS RIDGE RD SE DECISION MADE: 22-JUN-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
BIOSPHERE MEDICAL, INC. 510(k) NO: K061171(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 02-JUN-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL INTERPOROUS
BONYF AG 510(k) NO: K051342(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
SE DECISION MADE: 02-JUN-06
510(k) STATEMENT
DEVICE: MYTIS ARROW XXXX
BRAINBASE CORPORATION 510(k) NO: K052254(TRADITIONAL)
ATTN: CRAIG R BRUNS PHONE NO : 925-973-0710
10 MONTECITO DR. SE DECISION MADE: 01-JUN-06
DANVILLE, CA 94526 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION SPINE
BRAINLAB AG 510(k) NO: K053159(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 06-JUN-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL-B SONIC COMPLETE
BRAUN GMBH 510(k) NO: K061351(TRADITIONAL)
ATTN: AMANDA HEFFERNAN PHONE NO : 617-463-9532
800 BOYLSTON ST SE DECISION MADE: 05-JUN-06
PRUDENTIAL TOWER BLDG FL 46 510(k) SUMMARY AVAILABLE FROM FDA
BOSTON, MA 02199-8004
DEVICE: BREAS ISLEEP 20+
BREAS MEDICAL AB 510(k) NO: K061057(SPECIAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 463 186 8800
FORETAGSVAGEN 1 SE DECISION MADE: 23-JUN-06
MOLNLYCKE, SWEDEN 435 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK CO
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K060402(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 09-JUN-06
BATU BELAH 510(k) SUMMARY AVAILABLE FROM FDA
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: BRIVANT GUIDEWIRE
BRIVANT LIMITED 510(k) NO: K060551(TRADITIONAL)
ATTN: TOMAS FUREY PHONE NO : 011 353 91788960
4 WESTLINK COMMERCIAL PARK SE DECISION MADE: 07-JUN-06
ORANMORE, GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMLIGHT 10, MODEL 001-00030
CAO GROUP, INC. 510(k) NO: K061341(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
8683 SOUTH 700 WEST SE DECISION MADE: 12-JUN-06
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND
CARDINAL HEALTH 200, INC. 510(k) NO: K061308(SPECIAL)
ATTN: LAVENIA FORD PHONE NO : 847-785-3323
1500 WAUKEGAN ROAD SE DECISION MADE: 05-JUN-06
MCGAW PARK, IL 60685 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WDS, SIZE 2 AND SIZE 2
CEFLA S.C.R.L. 510(k) NO: K061114(ABBREVIATED)
ATTN: CLAUDE BERTHOIN PHONE NO : 386-672-0450
110 E GRANADA BLVD. SE DECISION MADE: 06-JUN-06
SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA
ORMOND BEACH, FL 32176
DEVICE: BLOOD PRESSURE METER, MODEL CH-311B
CITIZEN WATCH CO., LTD. 510(k) NO: K061161(SPECIAL)
ATTN: JOSEPH D EDMONDSON JR. PHONE NO : 202-672-5354
3000 K STREET, N.W., SUITE 500 SE DECISION MADE: 26-JUN-06
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: ULTRATINE TRANSBLEPH
COAPT SYSTEMS, INC. 510(k) NO: K060248(TRADITIONAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647
1820 EMBARCADERO RD. SE DECISION MADE: 12-JUN-06
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRATINE FOREHEAD
COAPT SYSTEMS, INC. 510(k) NO: K060249(TRADITIONAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647
1820 EMBARCADERO RD. SE DECISION MADE: 12-JUN-06
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOMMANDER PLUS
COLLABORATIVEMED, LLC 510(k) NO: K061110(TRADITIONAL)
ATTN: ROBERT BOOTH PHONE NO : 864-370-3297
14-D PELHAM RIDGE DRIVE SE DECISION MADE: 07-JUN-06
GREENVILLE, SC 29615 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURAB
COLLAGEN MATRIX, INC. 510(k) NO: K061487(SPECIAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 26-JUN-06
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPIVISION DIGITAL IMAGING SYSTEM
COMMUNICATIONS & POWER INDUSTRIES 510(k) NO: K061173(TRADITIONAL)
ATTN: NORM MORIKAWA PHONE NO : 905 877 0161
45 RIVER DRIVE SE DECISION MADE: 09-JUN-06
GEORGETOWN,ONTARIO, CANADA L7G 2J4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
CONFLUENT SURGICAL,INC 510(k) NO: K061183(SPECIAL)
ATTN: ERIC P ANKERUD PHONE NO : 781-693-2333
101A FIRST AVE. SE DECISION MADE: 01-JUN-06
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERVICE MANAGER SM40SE
CONMED INTEGRATED SYSTEMS, CANADA,510(k) NO: K053464(TRADITIONAL)
ATTN: MICHAEL T TAGGART PHONE NO : 727-399-5334
11311 CONCEPT BLVD SE DECISION MADE: 06-JUN-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIPI
CONTIPI LTD. 510(k) NO: K060526(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW COURT SE DECISION MADE: 09-JUN-06
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOHYSTEROGRAPHY BIOPSY DEVICE
COOK UROLOGICAL, INC. 510(k) NO: K060908(TRADITIONAL)
ATTN: CINDY RUMPLE PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 29-JUN-06
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT
COPAN DIAGNOSTICS, INC. 510(k) NO: K061301(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 23-JUN-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTICOVER SKIN BARRIER DEVICE
D & D HOLDINGS, LLC 510(k) NO: K042955(TRADITIONAL)
ATTN: MARK CITRON PHONE NO : 615-481-8198
10 WYNSTONE SE DECISION MADE: 19-JUN-06
NASHVILLE, TN 37215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
DADE BEHRING, INC. 510(k) NO: K061218(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 30-JUN-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
DADE BEHRING, INC. 510(k) NO: K061503(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454
P.O. BOX 6101 MS 514 SE DECISION MADE: 22-JUN-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAN MONOPOLAR LAP ACCESSORIES
DANNORITZER MEDIZINTECHNIK GMBH & 510(k) NO: K052759(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : +31 204 289591
AMSTEL-320-I SE DECISION MADE: 14-JUN-06
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION
DATEX-OHMEDA, INC. 510(k) NO: K060862(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 05-JUN-06
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA AISYS
DATEX-OHMEDA, INC. 510(k) NO: K061609(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 27-JUN-06
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K061314(TRADITIONAL)
ATTN: ROBIN N DRAGO PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 02-JUN-06
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
DELTA ENTERPRISE CORPORATION 510(k) NO: K052513(TRADITIONAL)
ATTN: MARIA E CELIS PHONE NO : 212-635-2730
17 STATE STREET, 19TH FLOOR SE DECISION MADE: 28-JUN-06
NEW YORK, NY 10004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDY ORTHODONTIC SCREW
DENTIUM CO., LTD. 510(k) NO: K060500(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 16-JUN-06
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTIUM II
DENTIUM CO., LTD. 510(k) NO: K060501(ABBREVIATED)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 16-JUN-06
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-IMPRESSION CONDITIONING SOLUTION
DENTSPLY INTL. 510(k) NO: K061427(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 26-JUN-06
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: FASTIN RC ANCHOR
DEPUY MITEK 510(k) NO: K060664(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988
325 PARAMOUNT DRIVE SE DECISION MADE: 06-JUN-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILAGRO INTERFERENCE SCREW
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K060830(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988
325 PARAMOUNT DR. SE DECISION MADE: 15-JUN-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY GLOBAL AP SHOULDER SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060874(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JUN-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K061144(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-267-8143
700 ORTHOPAEDIC DR. SE DECISION MADE: 08-JUN-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: VIPER SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K061520(SPECIAL)
ATTN: MARY GRAY PHONE NO : 508-828-3649
325 PARAMOUNT DR. SE DECISION MADE: 23-JUN-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMATECH IV HOLDER
DERMATECH MEDICAL INC 510(k) NO: K060488(TRADITIONAL)
ATTN: GLENN THIBAULT PHONE NO : 303-596-1108
102 HERITAGE AVE SE DECISION MADE: 08-JUN-06
CASTLE ROCK, CO 80104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE TIP SYRINGE
DEVON SAFETY PRODUCTS, INC. 510(k) NO: K060668(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 12-JUN-06
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND H
DIAZYME LABORATORIES 510(k) NO: K061296(SPECIAL)
ATTN: ROLAND STRICKLAND PHONE NO : 858-455-4761
3550 GENERAL ATOMICS CT. SE DECISION MADE: 13-JUN-06
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: CONFIDENCE HIGH VISCOSITY BONE CEMENT
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K060300(TRADITIONAL)
ATTN: HILA WACHSLER-AVRAHAMI PHONE NO : 972 9 9511511
11 HA'HOSHLIM ST. SE DECISION MADE: 21-JUN-06
HERZLIYA, ISRAEL 46724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K060876(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 15-JUN-06
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE S
DOLPHIN MEDICAL INC. 510(k) NO: K060524(SPECIAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389
9433 S. MORNING GLORY LN. SE DECISION MADE: 15-JUN-06
HIGHLANDS RANCH, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
DR. HOWARD MARTIN, P.A. 510(k) NO: K051573(TRADITIONAL)
ATTN: KYLE H SIBINOVIC PHONE NO : 301-695-1200
4327 REELS MILL RD. SE DECISION MADE: 26-JUN-06
FREDERICK, MD 21704 510(k) STATEMENT
DEVICE: CARINA HOME
DRAEGER MEDICAL B.V. 510(k) NO: K060705(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-721-5400
3135 QUARRY ROAD SE DECISION MADE: 14-JUN-06
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
DREW SCIENTIFIC LTD. 510(k) NO: K060510(TRADITIONAL)
ATTN: DIANE HILL PHONE NO : 441 229 432089
SOWERBY WOODS BUSINESS PARK SE DECISION MADE: 19-JUN-06
PARK ROAD 510(k) STATEMENT
BARROW IN FURNESS CUMBRIA, UNITED KINGDOM LA14 4QR
DEVICE: DUTECK BODY COMPOSITION ANALYZER
DUTECK INDUSTRIAL CO., LTD. 510(k) NO: K060642(TRADITIONAL)
ATTN: JOSEPH CHEN PHONE NO : 886 287 975035
3F-2, NO. 26, 513 LANE SE DECISION MADE: 07-JUN-06
JUI-KUANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 114
DEVICE: DYNATRON ION IONTOPHORESIS ELECTRODE
DYNATRONICS CORP. 510(k) NO: K060814(TRADITIONAL)
ATTN: KELVYN CULLIMORE, JR PHONE NO : 801-874-6251
7030 PARK CENTRE DR. SE DECISION MADE: 14-JUN-06
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
E-SAN LIMITED 510(k) NO: K061328(TRADITIONAL)
ATTN: KRISTIN M ZIELINSKI PHONE NO : 202-822-1853
2001 PENNSYLVANIA AVE. NW. SE DECISION MADE: 13-JUN-06
STE 575 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: EBI ESL PEEK-OPTIMA SPINE SYSTEM
EBI, L.P. 510(k) NO: K061016(SPECIAL)
ATTN: JENNIFER HARAKAL PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 08-JUN-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI ARRAY SPINAL SYSTEM
EBI, L.P. 510(k) NO: K061563(SPECIAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 23-JUN-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUCOGRAFT
ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K061244(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-772-5333
1300 I STREET, N.W. SE DECISION MADE: 06-JUN-06
11TH FLOOR EAST 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: QUIX DIGITAL RADIOGRAPHIC UPGRADE
EDGE MEDICAL DEVICES LTD. 510(k) NO: K052661(TRADITIONAL)
ATTN: VERED SCHARF PHONE NO : 972 974 13675
25 HATASIYA SE DECISION MADE: 07-JUN-06
RAANANA, ISRAEL 43654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT TURBO BILIARY STENT SYSTEM
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K061235(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2500
ONE EDWARDS WAY SE DECISION MADE: 05-JUN-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y-CLICK CONNECTOR
ELCAM MEDICAL ACAL 510(k) NO: K060759(TRADITIONAL)
ATTN: TALI HAZAN PHONE NO :
KIBUTZ BARAM SE DECISION MADE: 29-JUN-06
D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGI-MAX
ELLMAN INT'L INC. 510(k) NO: K061174(TRADITIONAL)
ATTN: JON GARITO PHONE NO : 516-267-6502
3333 ROYAL AVENUE SE DECISION MADE: 28-JUN-06
OCEANSIDE, NY 11572-3625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMJOI TENS DEVICE
EMJOI, INC. 510(k) NO: K052711(TRADITIONAL)
ATTN: MIKE JUDGE PHONE NO : 804-253-7274
2943 OAK LAKE BLVD. SE DECISION MADE: 23-JUN-06
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENDIUS ATAVI SYSTEM
ENDIUS, INC. 510(k) NO: K061345(SPECIAL)
ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 06-JUN-06
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MO
ENGINIVITY LLC 510(k) NO: K060537(TRADITIONAL)
ATTN: PENELOPE GRECO PHONE NO : 508-843-0282
8 GRAY LODGE ROAD SE DECISION MADE: 08-JUN-06
KITTERY, ME 03904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIDERX EMBOLIC PROTECTION DEVICE
EV3 INC. 510(k) NO: K053195(TRADITIONAL)
ATTN: BRENDA JOHNSON PHONE NO : 763-398-7238
4600 NATHAN LN. NORTH SE DECISION MADE: 23-JUN-06
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNAP II EEG MONITOR
EVEREST BIOMEDICAL INSTRUMENTS CO.510(k) NO: K060997(TRADITIONAL)
ATTN: RANDALL J KROHN PHONE NO : 636-519-7770
16690 SWINGLEY RIDGE RD. SE DECISION MADE: 15-JUN-06
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
CHESTERFIELD, MO 63017
DEVICE: EXACTECH EQUINOXE SHOULDER STEMS
EXACTECH, INC. 510(k) NO: K061454(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 12-JUN-06
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
FRESENIUS KABI DEUTSCHLAND GMBH 510(k) NO: K060316(TRADITIONAL)
ATTN: BARBARA BREUER-THAL PHONE NO : 490 617 26867785
DAIMLERSTRASSE 22 SE DECISION MADE: 23-JUN-06
BAD HOMBURG, GERMANY D-61352 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS
FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K061672(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 203-602-3775
419 WEST AVENUE SE DECISION MADE: 29-JUN-06
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FULLCARD ANALYSIS
GE HEALTHCARE 510(k) NO: K061587(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 23-JUN-06
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AUTOBONE2
GE HEALTHCARE 510(k) NO: K061625(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 26-JUN-06
MAILSTOP W-440 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: PRECISION THUNIS 800+
GE MEDICAL SYSTEMS, LLC 510(k) NO: K061028(ABBREVIATED)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 07-JUN-06
W-440 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188
DEVICE: INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA
GE MEDICAL SYSTEMS, LLC 510(k) NO: K061163(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 07-JUN-06
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
GENERAL ELECTRIC CO. 510(k) NO: K061129(SPECIAL)
ATTN: PATRICIA TAIGE PHONE NO : 414-721-3222
99000 INNOVATION DRIVE SE DECISION MADE: 01-JUN-06
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANQUIL TRI-BTE
GENERAL HEARING INSTRUMENTS, INC. 510(k) NO: K061459(SPECIAL)
ATTN: ROGER P JUNEAU PHONE NO : 504-733-3767
P.O. BOX 23748 SE DECISION MADE: 30-JUN-06
NEW ORLEANS, LA 70183-0748 510(k) STATEMENT
DEVICE: OSOM INFLUENZA A&B TEST
GENZYME CORP. 510(k) NO: K061508(TRADITIONAL)
ATTN: FRED D LASKY PHONE NO : 617-591-5512
ONE KENDALL SQUARE SE DECISION MADE: 12-JUN-06
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETAIN RADIOLUCENT SPACER
GLOBUS MEDICAL, INC. 510(k) NO: K061380(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 08-JUN-06
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS
GOOD MEDY ENTERPRISE LTD. 510(k) NO: K061007(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 229 044502
1 F., NO. 72, ALLEY 33 SE DECISION MADE: 14-JUN-06
LANE 514, JONGIENG ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHINGJUANG CITY, TAIPEI, CHINA (TAIWAN) 24255
DEVICE: PARTIAL OSSICULAR REPLACEMENT PROSTHESES
GRACE MEDICAL, INC. 510(k) NO: K060518(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000
8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 28-JUN-06
MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE WHISPER VIEW GUIDE WIRE
GUIDANT CORP. 510(k) NO: K061453(SPECIAL)
ATTN: KATHLEEN VITTUM PHONE NO : 651-582-4820
4100 HAMLINE AVE., NORTH SE DECISION MADE: 22-JUN-06
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILINK. 018 BILIARY STENT SYSTEM
GUIDANT ENDOVASCULAR SOLUTIONS, IN510(k) NO: K060817(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 951-914-2008
3200 LAKESIDE DR. SE DECISION MADE: 15-JUN-06
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MO
GVS SPA 510(k) NO: K061115(ABBREVIATED)
ATTN: DAWN I MOORE PHONE NO : 734-428-8988
20171 BOWENS RD SE DECISION MADE: 30-JUN-06
MANCHESTER, MI 48158-9600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE POWDER FREE NITRILE EXAMINATION GLOVES
HARTALEGA SDN BHD 510(k) NO: K052583(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 603 627 42177
9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 14-JUN-06
KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 52100
DEVICE: GLUCOPACK
HEALTHPIA AMERICA CORP. 510(k) NO: K052469(TRADITIONAL)
ATTN: STEVEN KIM PHONE NO : 973-286-7676
211 WARREN STREET SE DECISION MADE: 05-JUN-06
NEWARK, NJ 07103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 1
HEMOCUE AB 510(k) NO: K061047(TRADITIONAL)
ATTN: ALLAN WHITE PHONE NO : 949-859-2630
40 EMPIRE DRIVE SE DECISION MADE: 08-JUN-06
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX POWDERED EXAMINATION GLOVE
HIGH MOMENTUM SDN BHD 510(k) NO: K060858(TRADITIONAL)
ATTN: HUE K FAH PHONE NO : 033 392 3375
LOT 4960, JALAN TERATAI BATU 6 SE DECISION MADE: 08-JUN-06
OFF JALAN MERU 510(k) SUMMARY AVAILABLE FROM FDA
KLANG, SELANGOR DARUL ESHSAN, MALAYSIA 41050
DEVICE: GENESIS OTC MONITOR
HONEYWELL HOMMED, LLC 510(k) NO: K061087(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DRIVE SE DECISION MADE: 09-JUN-06
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTRY OTC MONITOR
HONEYWELL HOMMED, LLC 510(k) NO: K061088(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DRIVE SE DECISION MADE: 09-JUN-06
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WI
HOSPIRA, INC. 510(k) NO: K061159(TRADITIONAL)
ATTN: THOMAS KOZMA PHONE NO : 224-212-4803
275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 26-JUN-06
D-389 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045-5045 THIRD PARTY REVIEW
DEVICE: IKOENGELO
IKOETECH, LLC. 510(k) NO: K061006(TRADITIONAL)
ATTN: HUIMIN CHAO PHONE NO : 713-600-2410
3000 RICHMOND, SUITE 200 SE DECISION MADE: 05-JUN-06
HOUSTON, TX 77098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMA SCREEN SPECIFIC IFOBT
IMMUNOSTICS, INC. 510(k) NO: K060463(TRADITIONAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770
3505 SUNSET AVE. SE DECISION MADE: 06-JUN-06
OCEAN, NJ 07712 510(k) STATEMENT
DEVICE: DEPOTONE
IMPRINT PHARMACEUTICALS LIMITED 510(k) NO: K061032(SPECIAL)
ATTN: MERVYN LITTLE PHONE NO : 44 208 2249958
53 LANGTON ROAD SE DECISION MADE: 21-JUN-06
EAST MOLESEY, SURREY, UNITED KINGD510(k) STATEMENT
DEVICE: INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
INFRAREDX, INC. 510(k) NO: K052908(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 781-221-0053
34 THIRD AVE SE DECISION MADE: 23-JUN-06
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
INNOVASIS, INC. 510(k) NO: K061147(TRADITIONAL)
ATTN: DAVID N MCKEAN PHONE NO : 801-261-2236
614 EAST 3900 SOUTH SE DECISION MADE: 30-JUN-06
SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIGHT HEAD COIL
INSIGHT NEUROIMAGING SYSTEMS LLC 510(k) NO: K061281(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733
11 CANTERBURY STREET SE DECISION MADE: 19-JUN-06
WORCHESTER, MA 01610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART USBLITE, MODEL M011120
INTELLIGENT HEARING SYSTEMS 510(k) NO: K061443(SPECIAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102
6860 S.W. 81ST ST. SE DECISION MADE: 23-JUN-06
MIAMI, FL 33143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILOT TEST OR DETECTIVE AUDIOMETERS
INTERACOUSTICS A/S 510(k) NO: K060883(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-903-4157
7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 23-JUN-06
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROG
INTERLAB S.R.L. 510(k) NO: K053571(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE ROAD SE DECISION MADE: 30-JUN-06
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: ICHEM 100 URINE CHEMISTRY ANALYZER
IRIS INTERNATIONAL, INC. 510(k) NO: K060280(TRADITIONAL)
ATTN: GERALD J HADDOCK PHONE NO : 818-709-1244
9172 ETON AVE. SE DECISION MADE: 13-JUN-06
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
ISOVAC PRODUCTS LLC 510(k) NO: K052798(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775
540 COLLEGE ST SE DECISION MADE: 06-JUN-06
BELLAIRE, TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILKLINE SOFT RELINING KIT, MODEL 28-100100
J. MORITA USA, INC. 510(k) NO: K060844(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034
9 MASON SE DECISION MADE: 06-JUN-06
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: PORCELAIN PRIMER
J. MORITA USA, INC. 510(k) NO: K061322(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034
9 MASON SE DECISION MADE: 02-JUN-06
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLOR
JIANGSU EVERYGUARD PLASTIC PRODUCT510(k) NO: K060910(TRADITIONAL)
ATTN: CHU XIA OAN PHONE NO : 861 082 387441
RM 1606 BLDG 1JIANZIANG YUAN SE DECISION MADE: 07-JUN-06
NO 209 BEI SI HUAN SHONG RD HA 510(k) STATEMENT
BEIJING, CHINA
DEVICE: TRIDENT ANCHOR
JOHNSON & JOHNSON COMPANY 510(k) NO: K060914(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988
325 PARAMOUNT DRIVE SE DECISION MADE: 09-JUN-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-SHIELD PORT ACCESS INFUSION SET
KAWASUMI LABORATORIES, INC. 510(k) NO: K060580(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-830-5554
4723 OAK FAIR BLVD SE DECISION MADE: 06-JUN-06
TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
KAWASUMI LABORATORIES, INC. 510(k) NO: K061197(TRADITIONAL)
ATTN: SUZAN ONEL PHONE NO : 202-778-9134
1601 K STREET, N.W. SE DECISION MADE: 30-JUN-06
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERCH ARCH BAR, MODEL 38-690-00
KLS-MARTIN L.P. 510(k) NO: K061271(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 30-JUN-06
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: SIGMA 5000 SERIES, IMAGIC
KONTRON MEDICAL SYSTEMS SAS 510(k) NO: K061437(TRADITIONAL)
ATTN: LARRY WALKER PHONE NO : 800-365-6668
17725 N.E. 65TH STREET SE DECISION MADE: 14-JUN-06
BLDG. C 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98052-4911 THIRD PARTY REVIEW
DEVICE: KOWA KT-800
KOWA CO. LTD. 510(k) NO: K053444(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 81 596 370190
319 AKENO SE DECISION MADE: 09-JUN-06
OBATA-CHO, WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA
MIE-KEN, JAPAN 519-05
DEVICE: FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL
KYPHON, INC. 510(k) NO: K061210(SPECIAL)
ATTN: CINDY DOMECUS PHONE NO : 408-548-5421
1221 CROSSMAN AVE. SE DECISION MADE: 27-JUN-06
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
KYRON CLINICAL IMAGING, INC. 510(k) NO: K061255(TRADITIONAL)
ATTN: JAMES L REUSS PHONE NO : 414-727-1930
2457 N. MAYFAIR RD., SUITE 202 SE DECISION MADE: 13-JUN-06
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIB
LAB VISION CORP. 510(k) NO: K061360(TRADITIONAL)
ATTN: GRACE HSIAO-FEN CHANG PHONE NO : 510-991-2854
47777 WARM SPRINGS BLVD. SE DECISION MADE: 27-JUN-06
FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCE
LASERSCOPE 510(k) NO: K061646(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 800-243-9384
3070 ORCHARD DR. SE DECISION MADE: 27-JUN-06
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AFIBALERT ATRIAL FIBRILLATION DETECTOR
LECHNOLOGIES RESEARCH INC. 510(k) NO: K052767(TRADITIONAL)
ATTN: STEPHANIE KING PHONE NO : 763-287-3830
4050 OLSEN MEMORIAL HIGHWAY SE DECISION MADE: 23-JUN-06
MINNEAPOLIS, MN 55422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POINTER PLUS
LHASA OMS, INC. 510(k) NO: K060508(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1071
230 LIBBEY PKWY. SE DECISION MADE: 19-JUN-06
WEYMOUTH, MA 02189 510(k) STATEMENT
DEVICE: POINTER EXCEL
LHASA OMS, INC. 510(k) NO: K060517(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072
230 LIBBEY PKWY. SE DECISION MADE: 19-JUN-06
WEYMOUTH, MA 02189 510(k) STATEMENT
DEVICE: IR PRO 250
LHASA OMS, INC. 510(k) NO: K061080(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072
230 LIBBEY PKWY. SE DECISION MADE: 14-JUN-06
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOD POD
LIFE MEASUREMENT, INC. 510(k) NO: K060848(ABBREVIATED)
ATTN: MICHAEL SULLIVAN PHONE NO : 925-676-6002
1850 BATES AVE. SE DECISION MADE: 27-JUN-06
CONCORD, CA 94520-8586 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
LUCENT MEDICAL SYSTEMS 510(k) NO: K061240(SPECIAL)
ATTN: CYNTHIA PESTKA PHONE NO : 425-822-3310
811 KIRKLAND AVENUE; SUITE 100 SE DECISION MADE: 02-JUN-06
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LBI CATHETER SYSTEM
LUMEN BIOMEDICAL, INC. 510(k) NO: K053372(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 763-577-9600
2605 FERNBROOK LANE SE DECISION MADE: 30-JUN-06
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: MODEL MI 44 TYMPANOMETER
MAICO-DIAGNOSTICS 510(k) NO: K060885(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4457
7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 05-JUN-06
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
MAQUET CARDIOPULMONARY AG 510(k) NO: K061546(SPECIAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 49 747 89210
HECHINGER STRASSE 38 SE DECISION MADE: 20-JUN-06
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LNCS AND SPO2.COM SENSORS
MASIMO CORPORATION 510(k) NO: K060143(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7218
40 PARKER SE DECISION MADE: 16-JUN-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
MBL INTERNATIONAL CORPORATION 510(k) NO: K060431(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 19-JUN-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOTOOL DRUG DOSE CALCULATOR
MD SCIENTIFIC LLC 510(k) NO: K053137(TRADITIONAL)
ATTN: SHADE M MECUM PHONE NO : 704-335-1300
1214 WAREHAM COURT SE DECISION MADE: 14-JUN-06
CHARLOTTE, NC 28207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AG-PLUS, MODEL 91210
MEDEL S.P.A. 510(k) NO: K060404(ABBREVIATED)
ATTN: TERRENCE O'BRIEN PHONE NO : 919-468-9552
112 CAVISTON WAY SE DECISION MADE: 22-JUN-06
CARY, NC 27519 510(k) STATEMENT
DEVICE: MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
MEDELA AG 510(k) NO: K061205(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151
LAETTICHSTRASSE 4B SE DECISION MADE: 21-JUN-06
BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDELA VARIO 8 AND 18 SUCTION PUMPS
MEDELA AG 510(k) NO: K061435(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151
LAETTICHSTRASSE 4B SE DECISION MADE: 08-JUN-06
BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
MEDI-GLOBE CORPORATION 510(k) NO: K061684(TRADITIONAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2772
110 WEST ORION #136 SE DECISION MADE: 27-JUN-06
TEMPE, AZ 85248 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LUNG FLUTE
MEDICAL ACOUSTICS LLC 510(k) NO: K060439(TRADITIONAL)
ATTN: NICOLAAS J SMIT PHONE NO : 905-931-2311
255 GREAT ARROW AVE., SE DECISION MADE: 22-JUN-06
SUITE 23 510(k) SUMMARY AVAILABLE FROM FDA
BUFFALO, NY 14207
DEVICE: DEFIBRILLATOR CABLE TESTER, MODEL DT2200
MEDICAL DEVICES/PADPRO, INC. 510(k) NO: K061606(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-JUN-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COOL.CLICK 2
MEDICAL HOUSE PRODUCTS LIMITED 510(k) NO: K060819(TRADITIONAL)
ATTN: ROSE Y GUANG PHONE NO : 44 114 2619011
199 NEWHALL ROAD SE DECISION MADE: 16-JUN-06
SHEFFIELD, UNITED KINGDOM S9 2QJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE COLLAGEN WOUND DRESSING
MEDLINE INDUSTRIES, INC. 510(k) NO: K060456(ABBREVIATED)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 19-JUN-06
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PR
MEDTRADE PRODUCTS LTD. 510(k) NO: K061079(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
ELECTRA HOUSE SE DECISION MADE: 02-JUN-06
CREWE BUSINESS PARK 510(k) STATEMENT
CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K061254(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9083
7611 NORTHLAND DR. SE DECISION MADE: 23-JUN-06
MINNEAPOLIS, MN 55038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXA
MERETE MEDICAL GMBH 510(k) NO: K051965(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609
5349 RED LEAF COURT SE DECISION MADE: 16-JUN-06
OVIEDO, FL 32765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K060686(SPECIAL)
ATTN: ARIEL WANG PHONE NO : 886 287 971288
MAX SCHMIDHEINY-STRASSE 201 SE DECISION MADE: 09-JUN-06
HEERBRUGG, SWITZERLAND 9435 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K061403(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 14-JUN-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K061558(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-JUN-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
MITSUBISHI ELECTRIC CORPORATION KY510(k) NO: K061302(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190
319 AKENO, OBATA-CHO SE DECISION MADE: 23-JUN-06
ISE-SHI, JAPAN MIE-KEN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-USE ELECTRONIC PREGNANCY TEST
MIZUHO USA, INC. 510(k) NO: K060825(TRADITIONAL)
ATTN: BENEDICT ZIN PHONE NO : 858-679-0555
12131 COMMUNITY RD. SE DECISION MADE: 19-JUN-06
POWAY, CA 92064 510(k) STATEMENT
DEVICE: NANOLITE SKIN CARE SYSTEM
NANOLITE TECHNOLOGY, INC. 510(k) NO: K061117(ABBREVIATED)
ATTN: EDWIN BURGOS PHONE NO : 310-792-7070
21250 HAWTHORNE BLVD. SE DECISION MADE: 20-JUN-06
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
TORRANCE, CA 90503 THIRD PARTY REVIEW
DEVICE: V-2200 INFANT INCUBATOR
NEOFORCE GROUP, INC. 510(k) NO: K061280(TRADITIONAL)
ATTN: MARY STANIEWICZ PHONE NO : 215-672-6800
5985 HONEY HOLLOW RD. SE DECISION MADE: 27-JUN-06
DOYLESTOWN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SFB & CFB IMPLANTS
NOBEL BIOCARE AB 510(k) NO: K061003(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PARKWAY SE DECISION MADE: 30-JUN-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSSEOUS DENTAL IMPLANT
NORTHERN IMPLANTS, LLC 510(k) NO: K061169(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10355 B DEMOCRACY LANE SE DECISION MADE: 20-JUN-06
FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
O'BRIEN DENTAL LAB, INC. 510(k) NO: K060744(ABBREVIATED)
ATTN: SUZIE DOWNING PHONE NO : 541-754-1238
4311 SW RESEARCH WAY SE DECISION MADE: 02-JUN-06
CORVALLIS, OR 97333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH M
OLYMPUS AMERICA INC. 510(k) NO: K060201(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697
3131 W. ROYAL LANE SE DECISION MADE: 06-JUN-06
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K060243(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 23-JUN-06
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX KNEE SYSTEM
OMNI LIFE SCIENCE, INC. 510(k) NO: K060192(TRADITIONAL)
ATTN: EDWARD J CHEAL PHONE NO : 760-734-1577
175 PARAMOUNT DRIVE SE DECISION MADE: 15-JUN-06
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
RAYNHAM, MA 02767
DEVICE: PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
OMRON HEALTHCARE, INC. 510(k) NO: K060766(TRADITIONAL)
ATTN: DONNA DJINOVICH PHONE NO : 847-247-5713
1200 LAKESIDE DRIVE SE DECISION MADE: 09-JUN-06
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRA
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K060632(TRADITIONAL)
ATTN: LEAH DE WATER PHONE NO : 585-453-4131
100 INDIGO CREEK DR. SE DECISION MADE: 06-JUN-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR K
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K061464(SPECIAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253
100 INDIGO CREEK DR. SE DECISION MADE: 15-JUN-06
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCANEAL TRAUMA SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K061400(TRADITIONAL)
ATTN: LEE A STRNAD PHONE NO : 330-869-9563
1815 WEST MARKET ST. SE DECISION MADE: 29-JUN-06
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
AKRON, OH 44313
DEVICE: OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
OSTEOMED L.P. 510(k) NO: K060536(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 02-JUN-06
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)
OWANDY SAS 510(k) NO: K053172(TRADITIONAL)
ATTN: OLIVIER MAURIER PHONE NO : 164-111-818
1251 AVENUE OF THE AMERICAS SE DECISION MADE: 09-JUN-06
34TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10020
DEVICE: EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
PAJUNK GMBH 510(k) NO: K060563(TRADITIONAL)
ATTN: CHRISTAIN QUASS PHONE NO : 049 770 49291533
KARL-HALL-STRASSE 1 SE DECISION MADE: 02-JUN-06
GEISINGEN, GERMANY D-78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPILONG KIT FOR ANESTHESIOLOGY
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K060311(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49192533
KARL-HALL-STRASSE 1 SE DECISION MADE: 13-JUN-06
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC STAR WITH NASAL ADAPTER
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K061381(TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804-253-7274
2943 OAKLAKE BLVD. SE DECISION MADE: 02-JUN-06
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CZ-S2000
PARKELL, INC. 510(k) NO: K060946(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134
300 EXECUTIVE DR. SE DECISION MADE: 15-JUN-06
EDGEWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTROTILT MANUAL WHEELCHAIR
PDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K061475(TRADITIONAL)
ATTN: NANCY BALCOM PHONE NO : 604 323 9220
UNIT 102-366 E. KENT AVE. SE DECISION MADE: 14-JUN-06
SOUTH 510(k) STATEMENT
VANCOUVER, BC, CANADA V5X 4N6 THIRD PARTY REVIEW
DEVICE: PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
PEREGRINE SURGICAL LTD. 510(k) NO: K061024(TRADITIONAL)
ATTN: TODD RICHMOND PHONE NO : 215-348-0456
51 BRITAIN DR. SE DECISION MADE: 21-JUN-06
NEW BRITAIN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFIDOSE IM AUTO-INJECTOR
PHARMA-PEN, INC. 510(k) NO: K060389(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 13TH STREET, NW SE DECISION MADE: 06-JUN-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPO
PHD MEDICAL 510(k) NO: K060616(TRADITIONAL)
ATTN: NANCY RUTH PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 29-JUN-06
DUNDAS, ON, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRILLIANCE VOLUME
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K060937(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER RD. SE DECISION MADE: 05-JUN-06
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25,
POROUS MEDIA CORP. 510(k) NO: K061426(TRADITIONAL)
ATTN: DAVID RASCH PHONE NO : 651-653-2000
1350 HAMMOND RD. SE DECISION MADE: 05-JUN-06
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O
PRECISE MEDICAL PRODUCTS, LTD. 510(k) NO: K061409(SPECIAL)
ATTN: OFER SHAY PHONE NO : 972 498 09193
DORA ST. (INDUSTRIAL ZONE) SE DECISION MADE: 16-JUN-06
SHLOMI, ISRAEL 22832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVJET TURBO
PROMEDIC, INC. 510(k) NO: K060842(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 21-JUN-06
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
PT MAHAKARYA INTI BUANA 510(k) NO: K053305(TRADITIONAL)
ATTN: P. SASITHARAN NAIR PHONE NO : 626 179 44880
DESA DALU 10 A DUSUN 1 NO. 18 SE DECISION MADE: 02-JUN-06
TANJUNG MORAWA - 20362 510(k) SUMMARY AVAILABLE FROM FDA
SUMUT, INDONESIA, INDONESIA
DEVICE: R&D LH-NRBC HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K061320(SPECIAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413
614 MCKINLEY PL., N.E. SE DECISION MADE: 02-JUN-06
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERATHERM SOS-RESCUE BAG
R.G. ENTERPRISES, INC. 510(k) NO: K051336(TRADITIONAL)
ATTN: RONALD G LETOUTNEAU PHONE NO : 888-750-9498
21130 BRIDGE STREET SE DECISION MADE: 29-JUN-06
SOUTHFIELD, MI 48034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
RESPIRONICS, INC. 510(k) NO: K061034(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 23-JUN-06
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L4 OXYGEN CONCENTRATOR
RESPIRONICS, INC. 510(k) NO: K061261(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 28-JUN-06
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
RG ENT., INC. 510(k) NO: K051278(TRADITIONAL)
ATTN: RONALD G LETOURNEAU PHONE NO : 888-596-9498
21130 BRIDGE STREET SE DECISION MADE: 29-JUN-06
SOUTHFIELD, MI 48034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITRACT SAFETY SYRINGE
RITRACT LTD. 510(k) NO: K060002(TRADITIONAL)
ATTN: RUPERT NORTHCOTT PHONE NO : 61 2 89232511
201 MILLER STREET SE DECISION MADE: 02-JUN-06
LEVEL 17 510(k) SUMMARY AVAILABLE FROM FDA
NORTH SYDNEY, NEW SOUTH WALES, AUSTRALIA 2060
DEVICE: ONLINE TDM TOBRAMYCIN
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060853(TRADITIONAL)
ATTN: DIMIRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 09-JUN-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
RTC INC.-MEMCATH TECHNOLOGIES LLC 510(k) NO: K061324(TRADITIONAL)
ATTN: MARC JAKER PHONE NO : 651-450-7400
1777 OAKDALE AVE., SE DECISION MADE: 20-JUN-06
WEST ST. PAUL, MN 55118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
S.O.R. INTERNACIONAL, S.A. 510(k) NO: K052934(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727
SE DECISION MADE: 12-JUN-06
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
SEBIA 510(k) NO: K052291(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 734-475-2441
13805 WATERLOO SE DECISION MADE: 27-JUN-06
CHELSEA, MI 48118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARIAT LOOP APPLICATOR
SENTREHEART 510(k) NO: K060721(TRADITIONAL)
ATTN: ROBERT CHIN PHONE NO : 650-593-5225
2468 EMBARCADERO WAY SE DECISION MADE: 02-JUN-06
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIGENT GENTAMICIN
SERADYN INC. 510(k) NO: K060709(TRADITIONAL)
ATTN: EARL E KNIGHT PHONE NO : 317-554-0639
7998 GEORGETOWN RD. SE DECISION MADE: 15-JUN-06
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46268-5260
DEVICE: CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K061488(SPECIAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302
7263 CRONIN CIRCLE SE DECISION MADE: 30-JUN-06
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTS-7700
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K061083(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302
473 SAPENA COURT SE DECISION MADE: 06-JUN-06
SUITE #26 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 94568
DEVICE: VS-800 VITAL SIGNS MONITOR
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K060281(TRADITIONAL)
ATTN: SUSAN D GOLSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-JUN-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K061189(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 01-JUN-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAI-R
SHL MEDICAL, USA 510(k) NO: K060141(TRADITIONAL)
ATTN: LUCIO GIAMBATTISTA PHONE NO : 973-822-3007
23 VREELAND RD., SE DECISION MADE: 12-JUN-06
SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA
FLORHAM PARK, NJ 07932
DEVICE: GALILEOS IMPLANT, V 1.0
SICAT GMBH & CO. KG 510(k) NO: K061472(TRADITIONAL)
ATTN: MARKUS PARKER PHONE NO : 49 228 854697
BRUNNENALLEE 6 SE DECISION MADE: 09-JUN-06
BONN, GERMANY D-53177 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-
SICEL TECHNOLOGIES, INC. 510(k) NO: K061051(TRADITIONAL)
ATTN: TAMMY B CARREA PHONE NO : 919-465-2236
3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 13-JUN-06
SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SYNGO TRUED, MODEL VC10A
SIEMENS MEDICAL SOLUTIONS 510(k) NO: K061671(TRADITIONAL)
ATTN: JAMES E KUHN PHONE NO : 610-484-3006
20 VALLEY STREAM PARKWAY SE DECISION MADE: 29-JUN-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SMDIE DEVICE INTERFACING SYSTEM
SIEMENS MEDICAL SOLUTIONS HEALTH S510(k) NO: K061590(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 21-JUN-06
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759 THIRD PARTY REVIEW
DEVICE: COHERENCE DOSIMETRIST, MODEL 2.2
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K061097(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 925-602-8011
4040 NELSON AVE. SE DECISION MADE: 07-JUN-06
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCENIUM 1.1
SIEMENS MOLECULAR IMAGING LTD 510(k) NO: K061545(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-304-7516
2501 N. BARRINGTON ROAD SE DECISION MADE: 30-JUN-06
HOFFMAN ESTATES, IL 60195 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMB ANTIMICROBIAL DRESSING
SILVERLEAF MEDICAL PRODUCTS, INC. 510(k) NO: K060237(TRADITIONAL)
ATTN: DEBBIE KOENEMAN PHONE NO : 480-921-4948
1100 E UNIVERSITY DRIVE SE DECISION MADE: 15-JUN-06
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85281
DEVICE: REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
SMITH & NEPHEW, INC. 510(k) NO: K060630(ABBREVIATED)
ATTN: KATIE LOGEROT PHONE NO : 901-399-5778
1450 BROOKS RD. SE DECISION MADE: 14-JUN-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
SMITH & NEPHEW, INC. 510(k) NO: K061019(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 06-JUN-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINSA SUTURE ANCHOR
SMITH & NEPHEW, INC. 510(k) NO: K061154(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 08-JUN-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTRE
SMITH & NEPHEW, INC. 510(k) NO: K061352(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 08-JUN-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
SMITHS MEDICAL INTERNATIONAL 510(k) NO: K060945(TRADITIONAL)
ATTN: STEWART LEE PHONE NO : 44 170 6233806
1 ST. CRISPIN WAY SE DECISION MADE: 19-JUN-06
HASLINGDEN 510(k) STATEMENT
ROSSENDALE, LANCASHIRE, UNITED KINGDOM BB4 4PW
DEVICE: 4CIS VANE SPINE SYSTEM
SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K060702(TRADITIONAL)
ATTN: SAEYOUNG AHN PHONE NO : 301-469-7912
7612 BARNUM ROAD SE DECISION MADE: 22-JUN-06
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT HEATER-COOLER SYSTEM 3T
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K052601(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-JUN-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT S5 SYSTEM
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K060053(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 02-JUN-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR
SORIN GROUP ITALIA S.R.L. 510(k) NO: K061031(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
200 WEST STREET SE DECISION MADE: 02-JUN-06
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
SORIN GROUP ITALIA S.R.L. 510(k) NO: K061527(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
200 WEST STREET SE DECISION MADE: 27-JUN-06
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482
SPACELABS MEDICAL INC. 510(k) NO: K060900(TRADITIONAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 23-JUN-06
PO BOX 7018 510(k) SUMMARY AVAILABLE FROM FDA
ISSAQUAH, WA, WA 98027-7018
DEVICE: SSP PEDICLE SCREW SYSTEM
SPECIALTY SPINE PRODUCTS, LLC 510(k) NO: K060118(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 08-JUN-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
SPINAL EDGE, LLC 510(k) NO: K060916(TRADITIONAL)
ATTN: CHRISTINA VACCA PHONE NO : 440-315-6973
25125 DETROIT ROAD SE DECISION MADE: 08-JUN-06
WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
SSL AMERICAS, INC. 510(k) NO: K060098(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2152
3585 ENGINEERING DR. SE DECISION MADE: 08-JUN-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: SOCKET GRAFT
STEINER LABORATORIES 510(k) NO: K052493(TRADITIONAL)
ATTN: GREGORY GENE STEINER PHONE NO : 949-306-9491
590 FARRINGTON HWY. SE DECISION MADE: 09-JUN-06
#524 SUITE 132 510(k) STATEMENT
KAPOLEI, HI 96707
DEVICE: VASHE WOUND CLEANSING SYSTEM
STERILOX TECHNOLOGIES, INC. 510(k) NO: K060901(TRADITIONAL)
ATTN: HOWARD K MANN PHONE NO : 610-341-1899
320 KING OF PRUSSIA ROAD, SE DECISION MADE: 29-JUN-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
RADNOR, PA 19087
DEVICE: VERIFY SYSTEM 1 BIOLOGICAL MONITORING KIT 24 HR RIT
STERIS CORPORATION 510(k) NO: K060568(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 29-JUN-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
SUNTECH MEDICAL, INC. 510(k) NO: K060820(ABBREVIATED)
ATTN: DAVID GALLICK PHONE NO : 919-654-2332
507 AIRPORT BOULEVARD SE DECISION MADE: 07-JUN-06
SUITE 117 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: ENSEAL PTC TISSUE SEALING DEVICE
SURGRX INC 510(k) NO: K061526(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DRIVE SE DECISION MADE: 15-JUN-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
SYNERGEYES, INC. 510(k) NO: K061120(ABBREVIATED)
ATTN: RICHARD E LIPPMAN, O.D. PHONE NO : 240-683-3738
15825 SHADY GROVE ROAD SE DECISION MADE: 22-JUN-06
SUITE 30 510(k) STATEMENT
ROCKVILLE, MD 20850
DEVICE: SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
SYNTHES (USA) 510(k) NO: K060138(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY. SE DECISION MADE: 02-JUN-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JSZ MULTIACTION GP CONTACT LENS SOLUTION
SZABOCSIK AND ASSOCIATES 510(k) NO: K060924(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 NORTH WABASH AVE STE 1200 SE DECISION MADE: 28-JUN-06
CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMEN
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K061073(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 02-JUN-06
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LA
TECO DIAGNOSTICS 510(k) NO: K060364(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 15-JUN-06
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMATRIX DERMAL REPAIR SCAFFOLD
TEI BIOSCIENCES INC. 510(k) NO: K061407(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 29-JUN-06
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGERVIEW PROFESSIONAL
TELEVERE SYSTEMS 510(k) NO: K061035(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301-778-1700
6304 BELMONT CIRCLE BLDG 2 SE DECISION MADE: 05-JUN-06
MOUNT AIRY, MD 21771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAROTID ACCESS KIT
TERUMO MEDICAL CORP. 510(k) NO: K060666(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
125 BLUE BALL RD. SE DECISION MADE: 29-JUN-06
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER COLLAGEN REPAIR PATCH
TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K053562(TRADITIONAL)
ATTN: ANGELA BUNN PHONE NO : 678-342-7808
1141 CLARK STREET, SUITE D SE DECISION MADE: 23-JUN-06
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAG-IT CYSTIC FIBROSIS KIT
TM BIOSCIENCE CORPORATION 510(k) NO: K060627(SPECIAL)
ATTN: NANCY KRUNIC PHONE NO : 416 593 4323
439 UNIVERSITY AVE. SE DECISION MADE: 07-JUN-06
TORONTO, ONTARIO, CANADA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
TOKOTU ELECTRIC CO., LTD. 510(k) NO: K061061(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469
300 OYA, UEDA SE DECISION MADE: 07-JUN-06
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEMIO XG, SAA-580A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K061605(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 22-JUN-06
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ILED
TRUMPF KREUZER MEDIZIN SYSTEME GMB510(k) NO: K061317(TRADITIONAL)
ATTN: WILLIBALD HIEMER PHONE NO : 49 89 809070
BENZSTRASSE 26 SE DECISION MADE: 22-JUN-06
MUNCHEN, GERMANY 82178 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION M
TWIN STAR MEDICAL 510(k) NO: K060963(TRADITIONAL)
ATTN: CHET SIEVERT PHONE NO : 612-382-0888
1000 WESTGATE DRIVE, SUITE 117 SE DECISION MADE: 06-JUN-06
ST. PAUL, MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HE
TYCO HEALTHCARE GROUP 510(k) NO: K060509(TRADITIONAL)
ATTN: KEITH MARTIN PHONE NO : 508-261-8440
15 HAMPSHIRE ST. SE DECISION MADE: 23-JUN-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ SMART-168 GLUCOSE MONITORING SYSTEM
TYSON BIORESEARCH, INC. 510(k) NO: K052818(TRADITIONAL)
ATTN: NATHAN BEAVER PHONE NO :
SE DECISION MADE: 16-JUN-06
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US SPINE FACET FIXATION SYSTEM
US SPINE 510(k) NO: K061041(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999
13540 GUILD AVE SE DECISION MADE: 19-JUN-06
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
VARIAN INC 510(k) NO: K060896(TRADITIONAL)
ATTN: LORNA GAMBOA PHONE NO : 949-770-9381
25200 COMMERCENTRE DR. SE DECISION MADE: 09-JUN-06
LAKE FOREST, CA 92630-8810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO I VENT 201
VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K061627(SPECIAL)
ATTN: JERRY KORTEN PHONE NO : 845-770-2840
2 BLUE HILL PLAZA SE DECISION MADE: 29-JUN-06
BLDG. 2, 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PEARL RIVER, NY 10965
DEVICE: VITREA, VERSION 3.9
VITAL IMAGES, INC. 510(k) NO: K061624(TRADITIONAL)
ATTN: TIMOTHY J KAPPERS PHONE NO : 952-487-9624
5850 OPUS PARKWAY, SE DECISION MADE: 27-JUN-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW
DEVICE: VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
VOLCANO CORPORATION 510(k) NO: K060483(TRADITIONAL)
ATTN: MICHELLE J BADAL PHONE NO : 916-231-4497
2870 KILGORE RD. SE DECISION MADE: 23-JUN-06
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-VU CAD STATION
VUCOMP, INC. 510(k) NO: K061160(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 09-JUN-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
W.H.P.M., INC. 510(k) NO: K052197(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 09-JUN-06
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR S
WALTER LORENZ SURGICAL, INC. 510(k) NO: K061384(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-9443
1520 TRADEPORT DR. SE DECISION MADE: 06-JUN-06
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOYALA, SOYALA BLUE
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K060405(TRADITIONAL)
ATTN: ECKHARDT ALBERS PHONE NO : 011 494 0547020
KRONSAALSWEG 40 SE DECISION MADE: 21-JUN-06
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
WELCH ALLYN, INC. 510(k) NO: K053381(ABBREVIATED)
ATTN: CHRIS KLACZYK PHONE NO : 315-685-3694
4341 STATE ST. RD. SE DECISION MADE: 15-JUN-06
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AS101, BLOOD PRESSURE CUFF
WENZHOU LONGWAN MEDICAL INSTRUMENT510(k) NO: K060871(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 09-JUN-06
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIEDENT ESTETIC
XPDENT CORP. 510(k) NO: K061337(TRADITIONAL)
ATTN: CARMEN PEREZ PHONE NO : 305-233-3312
12145 S.W. 131ST AVE. SE DECISION MADE: 07-JUN-06
MIAMI, FL 33186 510(k) STATEMENT
DEVICE: ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
ZIEHM IMAGING, INC. 510(k) NO: K061203(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-718-2020
4181 LATHAM ST. SE DECISION MADE: 19-JUN-06
RIVERSIDE, CA 92501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER CONTOUR RESTORATIVE SYSTEM
ZIMMER DENTAL INC. 510(k) NO: K061043(TRADITIONAL)
ATTN: ERIN L MCVEY PHONE NO : 760-929-4166
1900 ASTON AVE. SE DECISION MADE: 27-JUN-06
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
ZIMMER GMBH 510(k) NO: K061211(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
P.O. BOX 708 SE DECISION MADE: 14-JUN-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 278
TOTAL WITH SUMMARIES 247
TOTAL WITH STATEMENTS 31
Updated May 2, 2007
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