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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 K010422
Device Name ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
Applicant
INNERSPACE, INC.
2933 SOUTH PULLMAN ST.,
SUITE A
SANTA ANA,  CA  92705
Applicant Contact DONALD E BOBO
Correspondent
INNERSPACE, INC.
2933 SOUTH PULLMAN ST.,
SUITE A
SANTA ANA,  CA  92705
Correspondent Contact DONALD E BOBO
Regulation Number882.1620
Classification Product Code
GWM  
Date Received02/12/2001
Decision Date 06/28/2001
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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