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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 K081773
Device Name OSV II
Applicant
INTEGRA NEUROSCIENCES IMPLANTS S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact JON CAPAROTTA
Correspondent
INTEGRA NEUROSCIENCES IMPLANTS S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact JON CAPAROTTA
Regulation Number882.5550
Classification Product Code
JXG  
Date Received06/23/2008
Decision Date 11/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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