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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 K121573
Device Name INTEGRA CAMINO ICP MONITOR
Original Applicant
INTRGRA LIFESCIENCES CORPORATION
311 enterprise drive
plainsboro,  NJ  08536
Original Contact erin doyle
Regulation Number882.1620
Classification Product Code
GWM  
Date Received05/29/2012
Decision Date 09/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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