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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
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