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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 K002392
Device Name VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
Applicant
INTEGRA NEUROCARE LLC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Applicant Contact NANCY MATHEWSON
Correspondent
INTEGRA NEUROCARE LLC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact NANCY MATHEWSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received08/07/2000
Decision Date 11/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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