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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 K033698
Device Name CONTOUR-FLEX VALVE AND SHUNT SYSTEM
Applicant
INTEGRA NEUROSCIENCES IMPLANTS S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
INTEGRA NEUROSCIENCES IMPLANTS S.A.
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/25/2003
Decision Date 12/17/2003
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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