Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K232924
Device Name T-Line® Hernia Mesh
Applicant
Deep Blue Medical Advances, Inc.
701 West Main Street, Suite 410
Durham,  NC  27701
Applicant Contact William Perry
Correspondent
Lince Consulting, LLC
111 Deerwood Road
Suite 200
San Ramon,  CA  94583
Correspondent Contact Diana DeGregorio
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/19/2023
Decision Date 10/18/2023
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
-
-