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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 K011168
Device Name NEUROGEN NERVE GUIDE
Applicant
Integra Lifesciences Corp.
105 Morgan Lane
Plainsboro,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
Integra Lifesciences Corp.
105 Morgan Lane
Plainsboro,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number882.5275
Classification Product Code
JXI  
Date Received04/17/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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