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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Collagen, Staple Line Reinforcement
510(k) Number K153364
Device Name Kerecis SecureMesh
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
Regulation Number878.3300
Classification Product Code
OXE  
Date Received11/20/2015
Decision Date 08/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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