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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 K260058
Device Name Kerecis Express (50250)
Applicant
Kerecis Limited
Sundastraeti 38
P.O. Box 151
Isafjordur,  IS 400
Applicant Contact Skuli Magnusson
Correspondent
Kerecis Limited
Sundastraeti 38
P.O. Box 151
Isafjordur,  IS 400
Correspondent Contact Skuli Magnusson
Classification Product Code
KGN  
Subsequent Product Code
FRO  
Date Received01/08/2026
Decision Date 10/30/2026
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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