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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, monitoring, intracranial pressure
510(k) Number K050720
Device Name NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
Applicant
INTEGRA NEUROSCIENCES
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact NANCY A MATHEWSON
Correspondent
INTEGRA NEUROSCIENCES
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact NANCY A MATHEWSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received03/21/2005
Decision Date 05/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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