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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, Absorbable, Abdominal Hernia
510(k) Number K163005
Device Name TIGR Matrix Surgical Mesh
Applicant
Novus Scientific AB
Virdings Alle
Uppsala,  SE 754 50
Applicant Contact MATS NORBERG
Correspondent
Novus Scientific AB
Virdings Alle
Uppsala,  SE 754 50
Correspondent Contact MATS NORBERG
Regulation Number878.3300
Classification Product Code
OWT  
Date Received10/28/2016
Decision Date 07/27/2017
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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