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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K213341
Device Name Fibrillar Collagen Wound Dressing
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
Classification Product Code
KGN  
Date Received10/07/2021
Decision Date 05/31/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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