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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
510(k) Number K182493
Device Name Bovine Pericardial Tissue Patch
Applicant
Tisgenx
15615 Alton Parkway, Suite 450
Irvine,  CA  92618
Applicant Contact Kris Kupumbati
Correspondent
Tisgenx
15615 Alton Parkway, Suite 450
Irvine,  CA  92618
Correspondent Contact Kris Kupumbati
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/11/2018
Decision Date 06/18/2019
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
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