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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 K241080
Device Name Kerecis Parvus (50207)
Applicant
Kerecis Limited
Sundstraeti 38, 400 Isafjordur
P.O. Box 151, 400 Isafjordur
Isafjordur,  IS
Applicant Contact William Kabitz
Correspondent
Kerecis Limited
Sundstraeti 38, 400 Isafjordur
P.O. Box 151, 400 Isafjordur
Isafjordur,  IS
Correspondent Contact William Kabitz
Classification Product Code
KGN  
Date Received04/19/2024
Decision Date 08/21/2024
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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