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 K182087
Device Name DynaMesh-POSTERIOR
Applicant
Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
Mbh
Prager Ring 70
Aachen,  DE D-52070
Applicant Contact Stefan Schneemelcher
Correspondent
Meddiquest Regulatory Affairs, Ltd.
Unit 73b Hebron Industrial Estate
Kilkenny,  IE R95 CRK2
Correspondent Contact Neil R. Armstrong
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/02/2018
Decision Date 10/31/2018
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
-
-