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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 K131541
FOIA Releasable 510(k) K131541
Device Name FLEXIBLE COOAGEN NERVE CUFF
Applicant
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Applicant Contact PEGGY HANSEN
Correspondent
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Correspondent Contact PEGGY HANSEN
Regulation Number882.5275
Classification Product Code
JXI  
Date Received05/29/2013
Decision Date 04/03/2014
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
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