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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, polymeric
510(k) Number K193144
Device Name T-Line Hernia Mesh
Applicant
Deep Blue Medical Advances, Inc.
701 W Main Street, Suite 410
Durham,  NC  27701
Applicant Contact William Perry
Correspondent
Lince Consulting, LLC
111 Deerwood Road, Suite 200
San Ramon,  CA  95483
Correspondent Contact Nancy Lince
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/13/2019
Decision Date 03/30/2020
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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