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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 K092395
Device Name OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact DONNA MILLISKY
Correspondent
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact DONNA MILLISKY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/05/2009
Decision Date 11/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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