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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 K962928
Device Name COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
Original Applicant
CAMINO NEUROCARE, INC.
5955 pacific center blvd.
san diego,  CA  92121
Original Contact donna l free
Regulation Number882.1620
Classification Product Code
GWM  
Date Received07/29/1996
Decision Date 12/20/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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