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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 K201577
Device Name MatriDerm
Applicant
Medskin Solutions Dr. Suwelack AG
Josef-Suwelack-Strasse 2
Billerbeck,  DE 48727
Applicant Contact Zuzana Hülsbusch
Correspondent
Medskin Solutions Dr. Suwelack AG
Josef-Suwelack-Strasse 2
Billerbeck,  DE 48727
Correspondent Contact Zuzana Hülsbusch
Classification Product Code
KGN  
Date Received06/11/2020
Decision Date 01/07/2021
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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