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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 K040201
Device Name MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
Applicant
Integra Neurosciences Implants S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
Integra Neurosciences Implants S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received01/29/2004
Decision Date 02/26/2004
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
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