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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 K190528
Device Name MariGen Wound Extra
Applicant
Kerecis Limited
Eyrargata 2
Isafjordur,  IS 400
Applicant Contact Gudmundur Fertram Sigurjonsson
Correspondent
Kerecis Limited
Eyrargata 2
Isafjordur,  IS 400
Correspondent Contact Gudmundur Fertram Sigurjonsson
Classification Product Code
KGN  
Date Received03/04/2019
Decision Date 07/10/2019
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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