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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 K863479
Device Name MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
Applicant
Medical Measurements, Inc.
53 Main St.
Hackensack,  NJ  07601
Applicant Contact WILLIAM SONES
Correspondent
Medical Measurements, Inc.
53 Main St.
Hackensack,  NJ  07601
Correspondent Contact WILLIAM SONES
Regulation Number882.1620
Classification Product Code
GWM  
Date Received09/09/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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