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 K003990
Device Name SOFRADIM PARIETEX SURGICAL MESHES
Applicant
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
SOFRADIM PRODUCTION
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/26/2000
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
-
-