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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 K133754
Device Name INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08535
Applicant Contact ELIZABETH MCMENIMAN
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08535
Correspondent Contact ELIZABETH MCMENIMAN
Regulation Number882.1620
Classification Product Code
GWM  
Date Received12/09/2013
Decision Date 03/06/2014
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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