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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 K191749
Device Name TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
Applicant
Novus Scientific AB
Virdings Alle 2
Uppsala,  SE se-754 50
Applicant Contact Thomas Engstrom
Correspondent
Cygnus Regulatory, LLC
5555 E Palo Verde Dr.
Paradise Valley,  AZ  85253
Correspondent Contact Loredana M Guseila
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
FTL   OOD  
Date Received07/01/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01622725
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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