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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 K121159
Device Name INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
Applicant
INTEGRA LIFESCIENCE CORPORTATION
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact STEVEN PELTIER
Correspondent
INTEGRA LIFESCIENCE CORPORTATION
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact STEVEN PELTIER
Regulation Number882.1620
Classification Product Code
GWM  
Date Received04/16/2012
Decision Date 07/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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