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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K130557
Device Name NEURAGEN 3D
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact STEPHEN H BEIER
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact STEPHEN H BEIER
Regulation Number882.5275
Classification Product Code
JXI  
Date Received03/04/2013
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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