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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 K221556
Device Name T-Line Hernia Mesh
Applicant
Deep Blue Medical Advances, Inc.
701 W Main St.
Suite 410
Durham,  NC  27701
Applicant Contact William Perry
Correspondent
Lincé Consulting, LLC
111 Deerwood Rd., Suite 200
San Ramon,  CA  94583
Correspondent Contact Nancy Lincé
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/31/2022
Decision Date 11/28/2022
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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