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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K251191
Device Name Collagen Dura Regeneration Membrane - Repair
Applicant
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Applicant Contact Victoria Augustine
Correspondent
Collagen Matrix, Inc.
15 Thornton Rd.
Oakland,  NJ  07436
Correspondent Contact Victoria Augustine
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received04/17/2025
Decision Date 11/18/2025
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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