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510(k) K133754

INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER by Integra LifeSciences Corporation — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2014
Date Received
December 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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