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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 K053244
Device Name LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
Applicant
Integra Lifesciences Corp.
311c Enterprise Dr.
Plainsboro,  NJ  08536
Applicant Contact JON CAPAROTTA
Correspondent
Integra Lifesciences Corp.
311c Enterprise Dr.
Plainsboro,  NJ  08536
Correspondent Contact JON CAPAROTTA
Regulation Number882.1620
Classification Product Code
GWM  
Date Received11/21/2005
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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