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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 K250864
Device Name MatriDerm pluS+ Bi-Layer
Applicant
Medskin Solutions Dr. Suwelack AG
Josef-Suwelack-Strasse 2
Billerbeck,  DE 48727
Applicant Contact Jan Hermes
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Classification Product Code
KGN  
Date Received03/21/2025
Decision Date 12/19/2025
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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