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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 K230227
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
Lince Consulting, LLC
111 Deerwood Rd.
Suite 200
San Ramon,  CA  94583
Correspondent Contact Nancy Lince
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/27/2023
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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