SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUL-2007 THROUGH 31-JUL-2007
DEVICE: UNO
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K071131(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169
ESPE PLATZ SE DECISION MADE: 25-JUL-07
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMES BOND 3
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K071260(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169
ESPE PLATZ SE DECISION MADE: 17-JUL-07
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-
A-DEC, INC. 510(k) NO: K070663(ABBREVIATED)
ATTN: THOMAS H LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 05-JUL-07
NEWBERG, OR 97132-9257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICOM SELF-SEALING STERILIZATION POUCH
A.R. MEDICOM, INC. 510(k) NO: K070428(TRADITIONAL)
ATTN: JASON LUDVIG PHONE NO : 514 636 6262
1200 55TH AVE. SE DECISION MADE: 17-JUL-07
MONTREAL, QUEBEC, CANADA H8T 3J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
ABBOTT SPINE, INC. 510(k) NO: K071174(SPECIAL)
ATTN: ZARA OAKES PHONE NO : 512-533-1929
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 25-JUL-07
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON U120 URINE ANALYZER, MODEL U111-101
ACON LABORATORIES, INC. 510(k) NO: K070929(TRADITIONAL)
ATTN: MARTIN O'CONNOR PHONE NO : 210-692-4192
4139 GARDENDALE CENTER, #101 SE DECISION MADE: 30-JUL-07
SAN ANTONIO, TX 78229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
ACRYMED, INC. 510(k) NO: K070333(TRADITIONAL)
ATTN: BRUCE GIBBONS PHONE NO : 503-624-9830
9560 SW NIMBUS AVE SE DECISION MADE: 10-JUL-07
BEAVERTON, OR 97008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED CONGRUENT BONE PLATE SYSTEM
ACUMED LLC 510(k) NO: K071715(SPECIAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 18-JUL-07
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGHPAK-12
AD ELEKTRONIK GMBH 510(k) NO: K062331(TRADITIONAL)
ATTN: GREGORY J MATHISON PHONE NO : 218-387-1559
3924 CASCADE BEACH ROAD SE DECISION MADE: 10-JUL-07
LUTSEN, MN 55612-9532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVER ALGINATE II WOUND DRESSING
ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K070581(TRADITIONAL)
ATTN: GRAHAME SOMERVILLE PHONE NO : 440 160 6863500
ROAD THREE SE DECISION MADE: 13-JUL-07
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
AGAMATRIX 510(k) NO: K071393(SPECIAL)
ATTN: CONNIE HERTEL PHONE NO : 603-328-6000
10 MAOR PARKWAY SE DECISION MADE: 20-JUL-07
SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
AGFA HEALTHCARE CORP. 510(k) NO: K071972(TRADITIONAL)
ATTN: TOM HOLBROOK PHONE NO : 519-746-6210
10 SOUTH ACADEMY ST. SE DECISION MADE: 30-JUL-07
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ONE STEP HCG PREGNANCY TEST
AI DE DIAGNOSTIC CO., LTD. 510(k) NO: K062703(TRADITIONAL)
ATTN: LIN WANG PHONE NO : 319-400-1131
1929 WOODBERRY COURT SE DECISION MADE: 23-JUL-07
IOWA CITY, IA 52246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOVENT 4000 WITH CPAP
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K070636(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400
1720 SUBLETTE AVE. SE DECISION MADE: 13-JUL-07
ST.LOUIS, MO 63110 510(k) STATEMENT
DEVICE: AOS UNIVERSAL CONECTING GUIDE TUBE
ALPHA-OMEGA SERVICES, INC. 510(k) NO: K062824(TRADITIONAL)
ATTN: BOB A ROBNETT PHONE NO : 562-804-0604
9156 ROSE ST SE DECISION MADE: 03-JUL-07
BELLFLOWER, CA 90706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
AMBU A/S 510(k) NO: K071186(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-768-6464
6740 BAYMEADOW DR. SE DECISION MADE: 30-JUL-07
GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-ABSORBABLE SILK SUTURE
ARROW INTL., INC. 510(k) NO: K071111(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 17-JUL-07
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FIBERWIRE
ARTHREX, INC. 510(k) NO: K071622(SPECIAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 03-JUL-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH
ASAHI INTECC CO., LTD. 510(k) NO: K071721(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 13-JUL-07
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGIC V2.0
ASHVA TECHNOLOGIES, PVT. LTD 510(k) NO: K071602(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 23-JUL-07
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE BIPOLAR SYSTEM
ATRICURE, INC. 510(k) NO: K043579(TRADITIONAL)
ATTN: ELSA C ABRUZZO, RAC PHONE NO : 513-755-4100
6033 SCHUMACHER PARK DR. SE DECISION MADE: 05-JUL-07
WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXYA SUTURE WELDING SYSTEM AND KIT
AXYA MEDICAL, INC. 510(k) NO: K070253(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 978-232-9997
100 CUMMINGS CENTER SE DECISION MADE: 11-JUL-07
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: TRELLIS-6 PERIPHERAL INFUSION SYSTEM
BACCHUS VASCULAR, INC. 510(k) NO: K071664(SPECIAL)
ATTN: ANTHONY SOWUNMI PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 13-JUL-07
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
BAYLIS MEDICAL CO., INC. 510(k) NO: K071745(SPECIAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875
2645 MATHESON BLVD. E SE DECISION MADE: 19-JUL-07
MISSISSAUGA, ONTARIO, CANADA L4W 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENVENUE BONE TAMP, MODEL SA 0044
BENVENUE MEDICAL, INC. 510(k) NO: K070293(TRADITIONAL)
ATTN: LAURENT SCHALLER PHONE NO : 650-934-0400
1235 PEAR AVENUE, #111 SE DECISION MADE: 10-JUL-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK TUMOR MARKER CONTROL
BIO-RAD LABORATORIES 510(k) NO: K071675(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 03-JUL-07
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
BIOMATERIALS KOREA INC. 510(k) NO: K063495(TRADITIONAL)
ATTN: KEVIN WALLS, RAC PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 26-JUL-07
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MBCP+
BIOMATLANTE 510(k) NO: K063527(TRADITIONAL)
ATTN: ADELINE FILLIATRE PHONE NO : 33 228 020009
5, RUE EDOUARD BELIN SE DECISION MADE: 30-JUL-07
VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET VISION FOOTRING SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K071395(TRADITIONAL)
ATTN: ROBERT FRIDDLE PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 09-JUL-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBTALAR IMPLANT
BIOMET SPORTS MEDICINE, INC. 510(k) NO: K071498(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 31-JUL-07
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOMET VARIABLE LOCKING PLATE SYSTEM
BIOMET TRAUMA 510(k) NO: K071325(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 26-JUL-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
BIOMET, INC. 510(k) NO: K071569(SPECIAL)
ATTN: ELIZABETH WRAY PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 02-JUL-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
BIOTRONIK, INC. 510(k) NO: K071665(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 18-JUL-07
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-CHROMA CRP TEST
BODITECH DIAGNOSTICS, INC. 510(k) NO: K062981(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 13-JUL-07
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: BLUE MAX BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K071309(TRADITIONAL)
ATTN: KARI CHRISTIANSON PHONE NO : 763-494-1969
ONE SCIMED PLACE SE DECISION MADE: 13-JUL-07
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:CONTOUR SE MICROSPHERES
BOSTON SCIENTIFIC CORP. 510(k) NO: K071634(SPECIAL)
ATTN: SHILPA PREM PHONE NO : 508-683-4234
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 12-JUL-07
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DL900 SERIES HOLTER RECORDER
BRAEMAR, INC. 510(k) NO: K071733(SPECIAL)
ATTN: DARREN DERSHEM PHONE NO : 800-328-2719
1285 CORPORATE CENTER DR. SE DECISION MADE: 24-JUL-07
SUITE 150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: BUSSE EPIDURAL CATHETER
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K070465(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
P.O. BOX 11067 SE DECISION MADE: 19-JUL-07
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANEUROPLASTIC, MODEL 43-1290
CODMAN & SHURTLEFF, INC. 510(k) NO: K071776(SPECIAL)
ATTN: RACHEL CREME PHONE NO : 508-828-2876
325 PARAMOUNT DR. SE DECISION MADE: 26-JUL-07
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
CODMAN & SHURTLEFF, INC. 510(k) NO: K071791(SPECIAL)
ATTN: RACHEL CREANE PHONE NO : 508-828-2876
325 PARAMOUNT DR. SE DECISION MADE: 30-JUL-07
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECHANICAL WHEELCHAIR - L-FRAME SERIES
COLOURS 'N MOTION 510(k) NO: K071444(TRADITIONAL)
ATTN: VICTOR R BOX PHONE NO : 951-808-9131
860 E PARKRIDGE AVE. SE DECISION MADE: 27-JUL-07
CORONA, CA 92879 510(k) STATEMENT
DEVICE: CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
CONFIRMA, INC. 510(k) NO: K071534(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-691-1400
11040 MAIN STREET SE DECISION MADE: 09-JUL-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
BELLEVUE, WA 98004
DEVICE: VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-
COOK, INC. 510(k) NO: K071640(SPECIAL)
ATTN: THEODORE HEISE PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 12-JUL-07
BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-VIEW BASIC AND PLUS
CORDATEC N.V. 510(k) NO: K070515(TRADITIONAL)
ATTN: BARBARA DEBIASE PHONE NO : 303-838-8816
1467 VIGILANTE AVE. SE DECISION MADE: 30-JUL-07
BAILEY, CO 80421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
CP MEDICAL 510(k) NO: K071550(ABBREVIATED)
ATTN: BETSY CORTELLONI PHONE NO : 770-831-4294
5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 18-JUL-07
BUFORD, GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIAL SOLUTION ORTHOSIS
CRANIAL SOLUTIONS 510(k) NO: K063133(TRADITIONAL)
ATTN: KIRK A LUCYK PHONE NO : 973-835-7929
602 LINCOLN AVE. SE DECISION MADE: 02-JUL-07
POMPTON LAKES, NJ 07442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
DADE BEHRING, INC. 510(k) NO: K070346(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 18-JUL-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL SEGAEGO 4D SCOOTER
DALTON MEDICAL CORP. 510(k) NO: K071282(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-5129
1103 VENTURE CT. SE DECISION MADE: 27-JUL-07
CARROLLTON, TX 75006 510(k) STATEMENT
DEVICE: MODEL SEGAEGO 3D SCOOTER
DALTON MEDICAL CORP. 510(k) NO: K071284(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-5129
1103 VENTURE CT. SE DECISION MADE: 26-JUL-07
CARROLLTON, TX 75006 510(k) STATEMENT
DEVICE: VR LUNG ELECTROSONOGRAPH
DEEP BREEZE LTD. 510(k) NO: K061495(TRADITIONAL)
ATTN: PHILIP J PHILLIPS PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVENUE NW SE DECISION MADE: 18-JUL-07
SUITE 575 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: DEPUY CAS HEMI ASR HIP INSTRUMENTS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071334(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 02-JUL-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071784(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 25-JUL-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K063772(TRADITIONAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 10-JUL-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HONEY ALGINATE DRESSING
DERMA SCIENCES CANADA, INC. 510(k) NO: K053095(TRADITIONAL)
ATTN: SHARMINI ATHERAY PHONE NO : 416 299 4003
104 SHORTING RD. SE DECISION MADE: 12-JUL-07
TORONTO, ONTARIO, CANADA M1S 3S4 510(k) STATEMENT
DEVICE: CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
DEXCO 510(k) NO: K070811(TRADITIONAL)
ATTN: ROBERT MAZZAFERRO PHONE NO : 301-216-2720
11 DELLCASTLE COURT SE DECISION MADE: 05-JUL-07
MONTGOMERY VILLAGE, MD 20886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND
DIESSE DIAGNOSTICA SENESE S.P.A 510(k) NO: K070062(TRADITIONAL)
ATTN: RAUL ALVAREZ PHONE NO : 305-827-5761
1690 W 38 PLACE SE DECISION MADE: 30-JUL-07
UNIT B1 510(k) SUMMARY AVAILABLE FROM FDA
HIALEAH, FL 33012 THIRD PARTY REVIEW
DEVICE: TRACKLEAF-10
DIREX SYSTEMS CORP. 510(k) NO: K071701(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 339-502-6013
437 TURNPIKE ST. SE DECISION MADE: 23-JUL-07
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY ANALYZER
DREW SCIENTIFIC, INC. 510(k) NO: K070704(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 13-JUL-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXDIAGNOSE
EEMAGINE MEDICAL IMAGING SOLUTIONS510(k) NO: K070358(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 30-JUL-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIWEB, VERSION 5.0
ELECTRONIC BUSINESS MACHINE CO., L510(k) NO: K071166(ABBREVIATED)
ATTN: ANDY YEW PHONE NO : 808-945-3100
1600 KAPIOLANI BLVD. SE DECISION MADE: 23-JUL-07
SUITE 1300 510(k) SUMMARY AVAILABLE FROM FDA
HONOLULU, HI 96814
DEVICE: STIFFER COAXIAL MICRO-INTRODUCER KIT
ENPATH MEDICAL, INC. 510(k) NO: K071574(SPECIAL)
ATTN: PATRICE STROMBERG PHONE NO : 763-951-8244
2300 BERKSHIRE LANE NORTH SE DECISION MADE: 05-JUL-07
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLAB40
ESAOTE EUROPE B.V. 510(k) NO: K070903(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N. MERIDIAN STREET SE DECISION MADE: 02-JUL-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: ENDO-CHX
ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K070401(TRADITIONAL)
ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-JUL-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACKPACK MEDICAL OXYGEN SYSTEM
ESSEX CRYOGENICS OF MISSOURI, INC.510(k) NO: K071581(TRADITIONAL)
ATTN: ELIZABETH HUNNICUTT PHONE NO : 314-832-8077
8007 CHIVVIS DR. SE DECISION MADE: 11-JUL-07
ST. LOUIS, MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FACIAL RECONSTRUCTIVE MESH (FRM)
EVERA MEDICAL, INC. 510(k) NO: K063154(TRADITIONAL)
ATTN: RANDY KESTEN PHONE NO : 650-287-2884
353 VINTAGE PARK DRIVE SE DECISION MADE: 10-JUL-07
SUITE F 510(k) SUMMARY AVAILABLE FROM FDA
FOSTER CITY, CA 94404
DEVICE: EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
EXACTECH, INC. 510(k) NO: K071676(SPECIAL)
ATTN: GRAHAM CUTHBERT PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 19-JUL-07
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
EZFIT TECHNOLOGY INC. 510(k) NO: K070299(TRADITIONAL)
ATTN: OU YANG PHONE NO : 886 625 57158
NO.42, SECTION 3, CHANG SHI RD SE DECISION MADE: 16-JUL-07
AN NAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAINAN CITY, CHINA (TAIWAN) 709 THIRD PARTY REVIEW
DEVICE: MICROTARGETING GUIDELINE 4000
FHC, INC. 510(k) NO: K071364(TRADITIONAL)
ATTN: LEE D MARGOLIN PHONE NO : 207-666-5651
1201 MAIN ST SE DECISION MADE: 25-JUL-07
BOWDOIN, ME 04287 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ABLE CENTRAL VENOUS CATHETER
FOSHAN NANHAI BAI HE MEDICAL TECHN510(k) NO: K070451(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D, NO.19 LANE 999, SE DECISION MADE: 31-JUL-07
ZHONG SHAN NAN ER ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 528200
DEVICE: OHMEDA MEDICAL GIRAFFE OMNIBED
GE HEALTHCARE 510(k) NO: K071175(SPECIAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN RD SE DECISION MADE: 17-JUL-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
GENESEE BIOMEDICAL, INC. 510(k) NO: K071214(SPECIAL)
ATTN: JOHN T WRIGHT PHONE NO : 303-777-3000
1308 SOUTH JASON ST. SE DECISION MADE: 31-JUL-07
DENVER, CO 80223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LG SPERM FREEZING
GENX INTL., INC. 510(k) NO: K070689(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW RD. SE DECISION MADE: 03-JUL-07
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL EXAMINATION GLOVES
GLORMED COLOMBIA S.A. 510(k) NO: K071022(TRADITIONAL)
ATTN: SAM KAO PHONE NO : 714-953-5326
2700 NORTH MAIN STREET SE DECISION MADE: 05-JUL-07
SUITE 506 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705
DEVICE: GSO GS1 SPINAL SYSTEM
GOLD STANDARD ORTHOPAEDICS, LLC 510(k) NO: K070966(TRADITIONAL)
ATTN: DAVID BAUGHMAN PHONE NO : 502-581-8770
1226 ROWAN ST. SE DECISION MADE: 20-JUL-07
LOUISVILLE, KY 40203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K063357(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 10-JUL-07
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMO
GX CORPORATION SDN BHD 510(k) NO: K071119(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 24-JUL-07
JALAN KAPAR 510(k) STATEMENT
KLANG, SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES
HIGH MOMENTUM SDN BHD 510(k) NO: K071208(TRADITIONAL)
ATTN: HUE K FAH PHONE NO : 603 339 23375
BANDAR BUKIT TINGGI KLANG SE DECISION MADE: 30-JUL-07
PELABUHAN KLANG 510(k) STATEMENT
SELANGOR DAURL EHSAN, MALAYSIA 42100
DEVICE: MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
HIGH MOMENTUM SDN BHD 510(k) NO: K071209(TRADITIONAL)
ATTN: HUE K FAH PHONE NO : 603 339 23375
BANDAR BUKIT TINGGI KLANG SE DECISION MADE: 25-JUL-07
PELABUHAN KLANG 510(k) STATEMENT
SELANGOR DAURL EHSAN, MALAYSIA 42100
DEVICE: CERMET III ACETABULAR CUP SYSTEM
IMPLANTS INTERNATIONAL, LTD 510(k) NO: K071583(TRADITIONAL)
ATTN: MOHAN EMMANUEL PHONE NO : 011 447 8433380023
71 JAY AVE.TEESIDE INDSTRL.EST SE DECISION MADE: 25-JUL-07
THORNABY-ON TEES 510(k) SUMMARY AVAILABLE FROM FDA
UNITED KINGDOM, UNITED KINGDOM T517-9LZ
DEVICE: INION BIORESTORE
INION OY 510(k) NO: K070784(TRADITIONAL)
ATTN: KATI MARTINEN PHONE NO : 358 10 8306600
LAAKARINKATU 2 SE DECISION MADE: 24-JUL-07
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHEELCHAIR MODEL STS
INNOVATIVE PRODUCTS, INC. 510(k) NO: K071390(ABBREVIATED)
ATTN: JIM STEINKE PHONE NO : 701-772-5185
830 S 48TH ST. SE DECISION MADE: 20-JUL-07
GRAND FORKS, ND 58201 510(k) STATEMENT
DEVICE: SIGMA M
INSTRUMENTARIUM DENTAL, PALODEX GR510(k) NO: K063837(TRADITIONAL)
ATTN: JOUNI ONNELA PHONE NO : 358 407 472550
NAHKELANTIE 160 SE DECISION MADE: 02-JUL-07
TUUSULA, FINLAND, FINLAND 04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTEP, MODEL M010000
INTELLIGENT HEARING SYSTEMS 510(k) NO: K070608(TRADITIONAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102
6860 S.W. 81ST ST. SE DECISION MADE: 18-JUL-07
MIAMI, FL 33143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELLNESSPRO 2010
INTELSOURCE GROUP, INC. 510(k) NO: K062616(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN SE DECISION MADE: 06-JUL-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CROFTON, MD 21114
DEVICE: SPINAL SPHERES
INTERBODY INNOVATIONS LLP 510(k) NO: K062992(TRADITIONAL)
ATTN: J D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 27-JUL-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
INVERNESS MEDICAL INNOVATIONS, INC510(k) NO: K071587(SPECIAL)
ATTN: JAMES DELANEY PHONE NO : 781-314-4185
51 SAWYER RD., SUITE 200 SE DECISION MADE: 30-JUL-07
WALTHAM, MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMI
KERR CORPORATION 510(k) NO: K071251(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 26-JUL-07
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYGUIDE
KEYSTONE DENTAL, INC. 510(k) NO: K071599(SPECIAL)
ATTN: MARTIN J LEIGHTON PHONE NO : 603-373-0260
161 LITTLE BAY RD. SE DECISION MADE: 11-JUL-07
NEWINGTON, NH 510(k) STATEMENT
DEVICE: KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K070183(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800
12554 WEST BRIDGER ST. SE DECISION MADE: 13-JUL-07
SUITE 108 510(k) STATEMENT
BOISE, ID 83713
DEVICE: EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
LAPIS LAZULI INTERNATIONAL NV 510(k) NO: K070767(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
2214 SANFORD DRIVE SUITE B7 SE DECISION MADE: 24-JUL-07
GRAND JUNCTION,, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL STEREOLOC II
LORAD, A HOLOGIC CO. 510(k) NO: K071542(SPECIAL)
ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203-731-8337
36 APPLE RIDGE RD. SE DECISION MADE: 05-JUL-07
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIC LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K070392(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 13-JUL-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
LYNTON LASERS LIMITED 510(k) NO: K063427(TRADITIONAL)
ATTN: ANDREW JOHN BERRY PHONE NO : 44 147 7536977
LYNTON HOUSE, MANOR LANE SE DECISION MADE: 25-JUL-07
HOLMES CHAPEL, CHESHIRE, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFE LATCH SHARPS & BIOHAZARD CONTAINER
M&M INDUSTRIES, INC. 510(k) NO: K071088(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DR. SE DECISION MADE: 05-JUL-07
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
MEDAPPS, INC. 510(k) NO: K062377(TRADITIONAL)
ATTN: KENT E DICKS PHONE NO : 480-951-0888
7975 NORTH HAYDEN ROAD SE DECISION MADE: 03-JUL-07
SUITE B-200 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85258
DEVICE: RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
MEDCOOL INC 510(k) NO: K070112(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 13-JUL-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIK
MEDICAL BIOMAT 510(k) NO: K070794(ABBREVIATED)
ATTN: AURELIEN BIGNON PHONE NO : 003 347 2814833
5, CHEMIN DU CATUPOLAN SE DECISION MADE: 10-JUL-07
VAULX-EN-VELIN, FRANCE 69120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEXAPOD RT COUCH TOP
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K071870(SPECIAL)
ATTN: MICHAEL WOLFF PHONE NO : 49 823 2969235
FEYERABENDSTRASSE 13-15 SE DECISION MADE: 08-JUL-07
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
MEDICAL MOLECULAR THERAPUETICS LLC510(k) NO: K063063(TRADITIONAL)
ATTN: ARTHUR B FLICK PHONE NO : 706-782-5064
36 LAKE RABUN RD. SE DECISION MADE: 03-JUL-07
LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
MEDICAL MOLECULAR THERAPUETICS LLC510(k) NO: K063069(TRADITIONAL)
ATTN: ARTHUR B FLICK PHONE NO : 706-782-5064
36 LAKE RABUN RD. SE DECISION MADE: 13-JUL-07
LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX-NECK ARC CATHETER
MEDIGROUP, INC. 510(k) NO: K070730(TRADITIONAL)
ATTN: JOHN A NAVIS PHONE NO : 630-554-5533
14 A STONEHILL RD. SE DECISION MADE: 03-JUL-07
OSWEGO, IL 60543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE LATEX FOLEY CATHETER
MEDLINE INDUSTRIES, INC. 510(k) NO: K071423(ABBREVIATED)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785
ONE MEDLINE PL. SE DECISION MADE: 18-JUL-07
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON THE GO SHARPS
MEDPORT, INC. 510(k) NO: K070577(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 13-JUL-07
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
MEDTRADE PRODUCTS LTD. 510(k) NO: K070175(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
ELECTRA HOUSE SE DECISION MADE: 25-JUL-07
CREWE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA
MEDTRONIC VASCULAR 510(k) NO: K071253(TRADITIONAL)
ATTN: JESSICA SIXBERRY PHONE NO : 763-391-9136
7611 NORTHLAND DR. SE DECISION MADE: 03-JUL-07
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FU
MEMOMETAL TECHNOLOGIES 510(k) NO: K070598(TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 332 990 55969
RUE BLAISE PASCAL SE DECISION MADE: 26-JUL-07
CAMPUS DE KER LANN 510(k) SUMMARY AVAILABLE FROM FDA
BRUZ, FRANCE F35170
DEVICE: ENDOCERVICAL ELECTRODE # 2
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K070877(TRADITIONAL)
ATTN: BOB STILLMAN PHONE NO : 804-353-7160
1705 DABNEY ROAD SE DECISION MADE: 27-JUL-07
RICHMOND, VA 23230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS SINUS IMPLANT STABILIZER
MONDEAL MEDICAL SYSTEMS GMBH 510(k) NO: K062436(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 011 312 04289591
AMSTEL 320-1 SE DECISION MADE: 30-JUL-07
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEPILEX AG DRESSING
MONLYCKE HEALTH CARE 510(k) NO: K071354(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PKWY. SE DECISION MADE: 13-JUL-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212
NCONTACT SURGICAL, INC. 510(k) NO: K071819(SPECIAL)
ATTN: JANE RICUPERO PHONE NO : 919-466-9810
1001 AVIATION PARKWAY SE DECISION MADE: 26-JUL-07
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SATURN 9000
NEW MEDICAL CO., LTD. 510(k) NO: K063710(TRADITIONAL)
ATTN: YOUNG-HOON SHIN PHONE NO : 886 287 916268
4F, NO.42, SINGZHONG RD. SE DECISION MADE: 16-JUL-07
NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: QWIX POSITIONING SCREW
NEWDEAL SAS 510(k) NO: K071639(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DR. SE DECISION MADE: 09-JUL-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
NEXA ORTHOPEDICS, INC. 510(k) NO: K071147(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 20-JUL-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 200
NI MEDICAL 510(k) NO: K070500(TRADITIONAL)
ATTN: JAMES COLLIE PHONE NO : 215-491-5245
414 MARYJOE WAY SE DECISION MADE: 16-JUL-07
WARRINGTON, PA 18976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4
NOBEL BIOCARE AB 510(k) NO: K071182(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 11-JUL-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
NOMOS CORP. 510(k) NO: K070611(TRADITIONAL)
ATTN: MARITA BRUST PHONE NO : 724-741-8200
200 WEST KENSINGER DR. SE DECISION MADE: 11-JUL-07
SUITE 100 510(k) STATEMENT
CRANBERRY TOWNSHIP, PA 16066
DEVICE: DIGITAL PULSE OXIMETER, MODEL 7500
NONIN MEDICAL, INC. 510(k) NO: K071285(SPECIAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 12-JUL-07
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
NOVA BIOMEDICAL CORP. 510(k) NO: K070960(SPECIAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 11-JUL-07
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KI
NOVARTIS NUTRITION CORP. 510(k) NO: K071191(TRADITIONAL)
ATTN: PHONE NO :
1541 PARK PLACE BLVD. SE DECISION MADE: 23-JUL-07
ST. LOUIS PARK, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
NOVOSCI CORP. 510(k) NO: K063355(TRADITIONAL)
ATTN: DAVID MAKANANI PHONE NO : 281-363-4949
2828 NORTH CRESCENT RIDGE DR. SE DECISION MADE: 27-JUL-07
THE WOODLANDS, TX 77381-3902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
NUCRYST PHARMACEUTICALS, INC. 510(k) NO: K063805(TRADITIONAL)
ATTN: STEVEN J CHARTIER PHONE NO : 781-224-1444
50 B AUDUBON RD. SE DECISION MADE: 13-JUL-07
WAKEFIELD, MA 01880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFT CONTAINMENT DEVICE
NUVASIVE, INC. 510(k) NO: K070148(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 31-JUL-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIRAFFE AND PANDA WARMER
OHMEDA MEDICAL 510(k) NO: K070377(TRADITIONAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN RD. SE DECISION MADE: 11-JUL-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WI
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K070983(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 05-JUL-07
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
OMRON HEALTHCARE, INC. 510(k) NO: K071645(SPECIAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK COURT #102 SE DECISION MADE: 02-JUL-07
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 0010
ONC SOLUTIONS, INC. 510(k) NO: K071673(TRADITIONAL)
ATTN: JOHN SCHWAMB PHONE NO : 603-566-5001
84 SUGAR HILL LANE SE DECISION MADE: 18-JUL-07
MANCHESTER, NH 03109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S)
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K071801(SPECIAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 20-JUL-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPORE, MODELS HA, BP90, BP15
ORTHOGEM LIMITED 510(k) NO: K070132(TRADITIONAL)
ATTN: ROD RUSTON PHONE NO : 011 44 908319295
BIOCITY, PENNYFOOT STREET SE DECISION MADE: 13-JUL-07
NOTTINGHAM, NOTTS, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
ORTHOPRO LLC 510(k) NO: K070555(TRADITIONAL)
ATTN: CHRISTOPHER COOK PHONE NO : 360-253-9761
13115 NE 4TH ST., SUITE 130 SE DECISION MADE: 13-JUL-07
VANCOUVER, WA 98684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06
ORTHOSOFT, INC. 510(k) NO: K071714(SPECIAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 878 9992
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 20-JUL-07
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTAC
OSTEOGENICS, INC. 510(k) NO: K061934(TRADITIONAL)
ATTN: MICHAEL DEUTSCH PHONE NO : 262-539-3564
7781 LAKEVIEW DR. SE DECISION MADE: 17-JUL-07
BURLINGTON, WI 53105-8119 510(k) STATEMENT
DEVICE: OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
OSTEOMED L.P. 510(k) NO: K071105(TRADITIONAL)
ATTN: DAWN D TINDALL PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 30-JUL-07
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PALOMAR LUXIR HANDPIECE
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K070298(SPECIAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414
82 CAMBRIDGE ST. SE DECISION MADE: 03-JUL-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K070973(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 03-JUL-07
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
PLUS ORTHOPEDICS AG 510(k) NO: K070731(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745
18 BRIDIE LANE SE DECISION MADE: 31-JUL-07
NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POINTE 360
POINTE SCIENTIFIC, INC. 510(k) NO: K062118(TRADITIONAL)
ATTN: RON JAMISON PHONE NO : 734-487-8300
5449 RESEARCH DRIVE SE DECISION MADE: 13-JUL-07
CANTON, MI 48188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042,
POSSIS MEDICAL, INC. 510(k) NO: K071342(TRADITIONAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 31-JUL-07
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
POSSIS MEDICAL, INC. 510(k) NO: K071514(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 31-JUL-07
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERLASER
POWERMEDIC APS 510(k) NO: K070516(TRADITIONAL)
ATTN: ARNE GRINSTED PHONE NO : 45 594 40832
KANALSTRAEDE 2 SE DECISION MADE: 02-JUL-07
HOLBAEK, DENMARK DK-4300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSOR
PROSURG, INC. 510(k) NO: K070737(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 25-JUL-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANC
PROSURG, INC. 510(k) NO: K070846(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 02-JUL-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSI BANDS
PSI HEALTH SOLUTIONS, INC. 510(k) NO: K070766(TRADITIONAL)
ATTN: ROMY TAORMINA PHONE NO : 831-373-7712
606 LIGHTHOUSE AVE. #168 SE DECISION MADE: 26-JUL-07
PACIFIC GROVE, CA 93950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
QUALITY GALLANT SDN. BHD. 510(k) NO: K071322(TRADITIONAL)
ATTN: SEAH B HOON PHONE NO : 605 849 4931
LOT 1874, JALAN KAMPUNG DEW SE DECISION MADE: 13-JUL-07
SIMPANG HALT 510(k) STATEMENT
TAIPING, PERAK, MALAYSIA 34700
DEVICE: ULTRAWAVE II EX 1320
QUANTA SYSTEM, S.P.A. 510(k) NO: K070805(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 11-JUL-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMA-CURE
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K071590(TRADITIONAL)
ATTN: PAUL GANGE PHONE NO : 630-773-4009
1540 WEST THORNDALE AVE. SE DECISION MADE: 31-JUL-07
ITASCA, IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTRAXX DATA CENTRE, MODEL R10
RESMED LTD. 510(k) NO: K070746(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 13-JUL-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPAP AUTO WITH H3I
RESMED LTD. 510(k) NO: K071171(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 10-JUL-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K071212(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 760-918-7458
2271 COSMOS CT. SE DECISION MADE: 30-JUL-07
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA1
RESTORATIVE THERAPIES INC. 510(k) NO: K071113(TRADITIONAL)
ATTN: ANDREW BARRISKILL PHONE NO : 800-609-9166
907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 05-JUL-07
BALTIMORE, MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTRAIT PSR
RHYTEC INCORPORATED 510(k) NO: K071786(SPECIAL)
ATTN: ROBERT ZOLETTI PHONE NO : 781-419-9482
130 TURNER STREET SE DECISION MADE: 26-JUL-07
WALTHAM, MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEW MD OFFICE SYSTEM, MODEL 41066.5540
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K071292(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 19-JUL-07
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS C 111 ANALYZER
ROCHE DIAGNOSTICS 510(k) NO: K071211(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 30-JUL-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ELECSYS PTH TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K070709(TRADITIONAL)
ATTN: KAY TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 13-JUL-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPIMED DISPOSABLE SIGMOIDOSCOPE
SAPIMED S.P.A. 510(k) NO: K070915(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN, SUITE A SE DECISION MADE: 06-JUL-07
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
SCIENCE FOR BIOMATERIALS 510(k) NO: K071155(TRADITIONAL)
ATTN: DENIS CLEMENT PHONE NO : 330 562 422101
ZI DU MONGE SE DECISION MADE: 03-JUL-07
LOURDES, FRANCE 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTI
SGMP CO., LTD. 510(k) NO: K071060(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 26-JUL-07
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - K
SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K071847(TRADITIONAL)
ATTN: SONGTAO ZHANG PHONE NO : 86 215 4500777801
6A, BUILDING-2, NO. 398 SE DECISION MADE: 23-JUL-07
TIANLIN RD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200233 THIRD PARTY REVIEW
DEVICE: MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K071882(TRADITIONAL)
ATTN: SONGTAO ZHANG PHONE NO :
6A, BUILDING-2, NO. 398 SE DECISION MADE: 18-JUL-07
TIANLIN RD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200233 THIRD PARTY REVIEW
DEVICE: MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL
SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K063757(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU CHIUN STREET SE DECISION MADE: 27-JUL-07
HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PC-60, NON-INVASIVEPULSE OXIMETER
SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K063641(TRADITIONAL)
ATTN: MACK CHARLES PHONE NO : 931-937-8093
340 SHADY GROVE RD SE DECISION MADE: 13-JUL-07
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
SHIJIAZHANG HONGXIANG PLASTIC PROD510(k) NO: K070852(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAFER AVE. SE DECISION MADE: 13-JUL-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE OEC ALTITUDE
SHIMADZU CORP. 510(k) NO: K071717(TRADITIONAL)
ATTN: AKIRA SHIGEYASU PHONE NO : 817 582 31305
1,NISHINOKYO-KUWABARACHO, SE DECISION MADE: 05-JUL-07
NAKAGYOKU 510(k) SUMMARY AVAILABLE FROM FDA
KYOTO CITY, JAPAN 604-8511 THIRD PARTY REVIEW
DEVICE: FL BOND II
SHOFU DENTAL CORP. 510(k) NO: K071452(TRADITIONAL)
ATTN: DAVID MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 09-JUL-07
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: SYNGO TRUED
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071950(TRADITIONAL)
ATTN: JAMES KUHN PHONE NO : 610-448-3006
20 VALLEY STREAM PKWY. SE DECISION MADE: 27-JUL-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AURORA LED SERIES SURGICAL LIGHTS
SKYTRON, DIV. THE KMW GROUP, INC. 510(k) NO: K071698(TRADITIONAL)
ATTN: LARRY PEREZ PHONE NO : 616-656-2900
5000 36TH ST., S.E. SE DECISION MADE: 06-JUL-07
GRAND RAPIDS, MI 49512 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANN
SMITH & NEPHEW, INC. 510(k) NO: K071300(TRADITIONAL)
ATTN: KATHY REDDIG PHONE NO : 978-749-1321
150 MINUTEMAN RD. SE DECISION MADE: 20-JUL-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
SMITHS MEDICAL PM, INC. 510(k) NO: K070732(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON DR. SE DECISION MADE: 09-JUL-07
WAUKESHA, WI 53186-1856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETEX POLYESTER MESH WITH INTRODUCER
SOFRADIM PRODUCTION 510(k) NO: K071629(SPECIAL)
ATTN: RENEE BORGESANO PHONE NO : 203-492-5325
HEALTHCARE GROUP SE DECISION MADE: 10-JUL-07
150 GLOVER AVE. 510(k) SUMMARY AVAILABLE FROM FDA
NORWALK, CT 06856
DEVICE: SOMNOSCREEN EEG10-20
SOMNOMEDICS GMBH 510(k) NO: K071556(SPECIAL)
ATTN: CHERITA JAMES PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 18-JUL-07
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSIO ICP MONITORING SYSTEM
SOPHYSA SA 510(k) NO: K062584(TRADITIONAL)
ATTN: ESTHER SALTZ PHONE NO : 949-463-8083
2884 DANAPOPLAR SE DECISION MADE: 05-JUL-07
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: STOCKERT S5 SYSTEM
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K071318(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-JUL-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
SOUNMED, INC. 510(k) NO: K071156(TRADITIONAL)
ATTN: JHOANA LORES PHONE NO : 305-477-0986
6800 N.W. 77TH COURT SE DECISION MADE: 03-JUL-07
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110
SOYEE PRODUCT, INC. 510(k) NO: K070634(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT RD. SE DECISION MADE: 11-JUL-07
SOUND BEACH, NY 11789 510(k) STATEMENT
DEVICE: CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM,
SPECTRANETICS CORP. 510(k) NO: K071227(TRADITIONAL)
ATTN: MICHAEL K HANDLEY PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 11-JUL-07
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2 MONITOR
SPECTRUM MEDICAL LTD 510(k) NO: K071725(TRADITIONAL)
ATTN: STEVE TURNER PHONE NO : 44 123 2650121
HARRIER 4,METEOR BUSINESS PARK SE DECISION MADE: 11-JUL-07
CHELTENHAM ROAD EAST 510(k) SUMMARY AVAILABLE FROM FDA
GLOUCESTER, GLOUCESTERHSIRE, UNITETHIRD PARTY REVIEW
DEVICE: SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
SPORT-ELEC S.A. 510(k) NO: K061914(TRADITIONAL)
ATTN: ARMELLE LAPRELLE PHONE NO : 331 690 70337
ROUTE DE POUEN BP 35 SE DECISION MADE: 26-JUL-07
BOURGTHEROULDE INFREVILLE, FRANCE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z6 STIMULATOR
ST CARDIO TECHNOLOGIES, LLC 510(k) NO: K070743(TRADITIONAL)
ATTN: BILL ABBOUD PHONE NO : 303-324-9417
3901 TROON CIRCLE SE DECISION MADE: 02-JUL-07
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F
STERIS CORPORATION 510(k) NO: K070461(ABBREVIATED)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 17-JUL-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
STRAUMANN USA 510(k) NO: K071585(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 11-JUL-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PEEK TWINLOOP TAC
STRYKER ENDOSCOPY 510(k) NO: K070882(TRADITIONAL)
ATTN: JEFF SEMONE PHONE NO : 408-754-2124
5900 OPTICAL CT. SE DECISION MADE: 20-JUL-07
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K070631(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 13-JUL-07
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
SUPERDIMENSION, LTD. 510(k) NO: K071473(TRADITIONAL)
ATTN: CLAY ANSELMO PHONE NO : 303-223-4303
555 ZANG STREET SE DECISION MADE: 12-JUL-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
LAKEWOOD, CO 80228
DEVICE: SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
SURGIQUEST, INC. 510(k) NO: K071571(TRADITIONAL)
ATTN: KOUROSH AZARBARZIN PHONE NO : 203-799-2400
12 CASCADE BLVD. SE DECISION MADE: 30-JUL-07
SUITE 2B 510(k) SUMMARY AVAILABLE FROM FDA
ORANGE, CT 06477
DEVICE: MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
SURGRX, INC. 510(k) NO: K071728(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DR. SE DECISION MADE: 13-JUL-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO KAVO QUATTROCARE
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K071288(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 19-JUL-07
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
SYMBIOS MEDICAL PRODUCTS, LLC 510(k) NO: K071735(SPECIAL)
ATTN: MICHAEL JAMES PHONE NO : 317-225-4447
7301 GEORGETOWN RD., SUITE 150 SE DECISION MADE: 19-JUL-07
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VELASMOOTH, SHAPER
SYNERON MEDICAL LTD. 510(k) NO: K070092(TRADITIONAL)
ATTN: YONI IGER PHONE NO : 972 490 96200
P.O. BOX 550 SE DECISION MADE: 27-JUL-07
INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM ILLIT, ISRAEL 20692
DEVICE: SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
SYNTERMED, INC. 510(k) NO: K071503(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
245 OWENS DR. SE DECISION MADE: 26-JUL-07
ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
SYNTHES (USA) 510(k) NO: K071264(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948
1301 GOSHEN PKWY SE DECISION MADE: 09-JUL-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810
TERRAY CORP. 510(k) NO: K063275(TRADITIONAL)
ATTN: STEVEN WILLIS PHONE NO : 613 623 3310
49 JACKSON LANE SE DECISION MADE: 27-JUL-07
PINE GROVE INDUSTRIAL PARK 510(k) STATEMENT
ARNPRIOR, CANADA K7S 3G8
DEVICE: CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
TERUMO CORP. 510(k) NO: K071494(TRADITIONAL)
ATTN: GARY COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 16-JUL-07
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FIL
TERUMO CORP. 510(k) NO: K071572(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 23-JUL-07
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO 31G THINPRO INSULIN SYRINGE
TERUMO MEDICAL CORP. 510(k) NO: K071630(SPECIAL)
ATTN: EILEEN DORSEY PHONE NO : 410-392-7241
950 ELKTON BLVD. SE DECISION MADE: 11-JUL-07
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILLAR PEDICLE SCREW SYSTEM
THE 4TH COLUMN, LLC 510(k) NO: K071743(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235
11234 EL CAMINO REAL,SUITE 200 SE DECISION MADE: 06-JUL-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VU E*POD VERTEBRAL BODY REPLACEMENT
THEKEN SPINE LLC 510(k) NO: K071031(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 30-JUL-07
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN
THEO MANUFACTURING BV 510(k) NO: K053613(TRADITIONAL)
ATTN: BARBARA DEBIASE PHONE NO : 303-838-8816
1467 VIGILANTE AVE. SE DECISION MADE: 25-JUL-07
BAILEY, CO 80421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSTOMIZED SOUND THERAPY (CST)
TINNITUS OTOSOUND PRODUCTS, LLC 510(k) NO: K070599(ABBREVIATED)
ATTN: GERALDINE CREAN PHONE NO : 310-927-6151
880 FIRST ST., SUITE 403 SE DECISION MADE: 13-JUL-07
LOS ANGELES, CA 90012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
TONICA ELEKTRONIK A/S 510(k) NO: K071821(SPECIAL)
ATTN: LISE TERKELSEN PHONE NO : 45 449 98444
LUCERNEMARKEN 15 SE DECISION MADE: 27-JUL-07
FARUM, DENMARK 3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K072000(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 30-JUL-07
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
TRIBOFILM RESEARCH, INC. 510(k) NO: K071027(TRADITIONAL)
ATTN: VINAY SAKHRANI PHONE NO : 919-838-2844
625 HUTTON STREET SE DECISION MADE: 20-JUL-07
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
RALEIGH, NC 27606
DEVICE: GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
VARIAN MEDICAL SYSTEMS 510(k) NO: K071381(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 18-JUL-07
M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: VARISOURCE IX HDR AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K071467(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 16-JUL-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDODRAPE
VORTEX SURGICAL, LLC 510(k) NO: K070406(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727
2454 MCMULLEN BOOTH ROAD, SE DECISION MADE: 30-JUL-07
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759 THIRD PARTY REVIEW
DEVICE: ALLEGRO OCULYZER
WAVELIGHT AG 510(k) NO: K071183(TRADITIONAL)
ATTN: ALEXANDER POPP PHONE NO : 011 499 1316186121
AM WOLFSMANTEL 5 SE DECISION MADE: 20-JUL-07
ERLANGEN, BAVARIA, GERMANY 91058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 276
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K071163(TRADITIONAL)
ATTN: ECKHARDT ALBERS PHONE NO : 011 494 054702180
KRONSAALSWEG 40 SE DECISION MADE: 18-JUL-07
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELMED HYPODERMIC SYRINGE
WELMED INC. 510(k) NO: K070936(ABBREVIATED)
ATTN: DARREN REEVES PHONE NO : 804-307-7706
15637 FOX COVE CIRCLE SE DECISION MADE: 16-JUL-07
MOSELEY, VA 23120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
WHITTLESTONE, INC. 510(k) NO: K070435(TRADITIONAL)
ATTN: GLEN THIBAULT PHONE NO : 303-596-1105
102 HERITAGE AVE SE DECISION MADE: 17-JUL-07
CASTLE ROCK, CO 80104-y 510(k) STATEMENT
DEVICE: DYNASTY ACETABULAR SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K070785(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 11-JUL-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEO CE LIGHT & ZEO QUICK PORCELAIN
XPDENT CORP. 510(k) NO: K071201(TRADITIONAL)
ATTN: CARMEN PEREZ PHONE NO : 305-233-3312
12145 S W 131 AVE SE DECISION MADE: 30-JUL-07
MIAMI, FL 33186 510(k) STATEMENT
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
XUZHOU FULL SUN MEDICAL PRODUCTS L510(k) NO: K071123(TRADITIONAL)
ATTN: HSUN-HUI HUANG PHONE NO : 886 285 093976
BIHE INDUSTRY AREA SE DECISION MADE: 30-JUL-07
YITANG TOWN, PIZHOU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
JIANGSU, CHINA
DEVICE: CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSE
ZEN STRONG MEDICAL TECHNOLOGY CO.,510(k) NO: K070578(TRADITIONAL)
ATTN: CHENG ROEI-SHENG PHONE NO : 886 224 570547
6F,NO.88 NING JING ST., SE DECISION MADE: 11-JUL-07
KEELUNG,, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K070317(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908-243-4924
200 EVANS WAY SE DECISION MADE: 05-JUL-07
BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER SEGMENTAL SYSTEM
ZIMMER, INC. 510(k) NO: K070978(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 03-JUL-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE
ZIMMER, INC. 510(k) NO: K071107(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 06-JUL-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY LONGEVITY CONSTRAINED LINER
ZIMMER, INC. 510(k) NO: K071718(TRADITIONAL)
ATTN: STEPHEN MCKELVEY PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 13-JUL-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM,
ZIMMER, INC. 510(k) NO: K071856(SPECIAL)
ATTN: DALENE BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 30-JUL-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 216
TOTAL WITH SUMMARIES 192
TOTAL WITH STATEMENTS 24
Updated December 13, 2007
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