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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 K153041
Device Name Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 Enterprise Drive
PLAINSBORO,  NJ  08536
Applicant Contact Timothy Connors
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 Enterprise Drive
PLAINSBORO,  NJ  08536
Correspondent Contact Timothy Connors
Regulation Number882.5550
Classification Product Code
JXG  
Date Received10/19/2015
Decision Date 03/14/2016
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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