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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 K042192
Device Name LOW FLOW OSV II HYDROCEPHALUS VALVE
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 Received08/12/2004
Decision Date 09/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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