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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 K982702
Device Name VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
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 Received08/03/1998
Decision Date 09/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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