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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name shunt, central nervous system and components
510(k) Number K022554
Device Name MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Applicant
INTEGRA NEUROSCIENCES
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact DONNA WALLACE
Correspondent
INTEGRA NEUROSCIENCES
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact DONNA WALLACE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/02/2002
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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