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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 K981846
Device Name PARENCHYMAL BOLT PRESSURE MONITORING KIT
Applicant
CAMINO NEUROCARE, INC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Applicant Contact JODY J FLEMING
Correspondent
CAMINO NEUROCARE, INC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact JODY J FLEMING
Regulation Number882.1620
Classification Product Code
GWM  
Date Received05/26/1998
Decision Date 08/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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