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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 K040235
Device Name LICOX PMO BRAIN MONITORING SYSTEM
Applicant
Integra Life Sciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact NANCY MATHEWSON
Correspondent
Integra Life Sciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact NANCY MATHEWSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received02/02/2004
Decision Date 04/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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