VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V


Device Classification Name

device, monitoring, intracranial pressure

510(k) Number K002392
Device Name VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
Original Applicant
INTEGRA NEUROCARE LLC.
5955 pacific center blvd.
san diego, 
CA 
92121

Original Contact nancy mathewson
Regulation Number 882.1620
Classification Product Code
GWM  
Date Received 08/07/2000
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