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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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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