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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
FOIA Releasable 510(k) K962928
Device Name COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
Applicant
CAMINO NEUROCARE, INC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Applicant Contact DONNA L FREE
Correspondent
CAMINO NEUROCARE, INC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Correspondent 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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