FDA 510(k) Applications for Medical Device:
Holder, Head, Neurosurgical (Skull Clamp)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K122225 BRAINLAB AG KAPELLENSTRASSE 12
FELDKIRCHEN 85622
K090695 DINKLER SURGICAL DEVICES, INC. 174 LOOKOUT DRIVE
DAYTON OH 45419
K073163 DINKLER SURGICAL DEVICES, INC. 174 LOOKOUT DRIVE
DAYTON OH 45419
K031885 IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD.
MELBOURNE FL 32935
K103493 IMRIS, INC. 16809 BRIARDALE ROAD
ROCKVILLE MD 20855
K141950 IMRIS, INC. 5101 Shady Oak Rd
Minnetonka MN 55343
K113748 IMRIS, INC. 100-1370 SONY PLACE
WINNIPEG, MB R3T 1N5
K051440 INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE
PLAINSBORO NJ 08536
K050319 INTEGRA LIFESCIENCES CORP. 4900 CHARLEMAR DRIVE,
CINCINATTI OH 45227
K081401 INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K072208 INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K130389 INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K090506 INTEGRA LIFESCIENCES CORPORATION 4900 CHARLEMAR DR.,
CINCINNATI OH 45227
K071458 INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K120633 INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K142238 INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K053045 INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR.
PLAINSBORO NJ 08536
K083803 MEDICON, E.G. GAENSAECKER 15
TUTTLINGEN D-78532
K955012 MIZUHO AMERICA, INC. 123 BRIMBAL AVE.
BEVERLY MA 01915
K191701 MRI Interventions, Inc. 5 Musick
Irvine CA 92618
K953124 OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE.
CINCINNATI OH 45227
K021604 OHIO MEDICAL INSTRUMENT CO., INC. 4900 CHARLEMAR DR.
CINCINNATI OH 45227
K191740 Pro Med Instruments GmbH Boetzinger Str. 38
Freiburg 79111
K203505 pro med instruments GmbH Boetziger Str. 38
Freiburg 79111
K191979 Pro Med Instruments GmbH Boetzinger Str. 38
Freiburg 79111
K193438 Pro Med Instruments GmbH Boetzinger Str. 38
Freiburg 79111
K001808 PRO-MED INSTRUMENTS GMBH 9070 BLUFFVIEW TRACE
ROSWELL GA 30076
K063494 PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1
LEHIGH ACRES FL 33971
K032331 PRO-MED INSTRUMENTS GMBH 1899 SAWYER LANE
ALVA FL 33920
K091439 SURGIVISION, INC. 11874 SOUTH EVELYN CIRCLE
HOUSTON TX 77071
K163322 TZ MEDICAL INC 17750 SW UPPER BOONES FERRY RD #150
PORTLAND OR 97224
K002276 V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H
SAN CARLOS CA 94070
K002990 VASCULAR TECHNOLOGY INCORPORATED 175 CABOT ST.
LOWELL MA 01854




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