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 K253125
Device Name Parietene™ Flat Sheet Mesh
Applicant
Medtronic - Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Applicant Contact Paula Paz
Correspondent
Medtronic - Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Correspondent Contact Paula Paz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/25/2025
Decision Date 10/24/2025
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
-
-