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 K060713
Device Name PROCEED SURGICAL MESH
Applicant
ETHICON INC.
ROUTE 22 WEST
PO BOX 151
SOMERVILLE,  NJ  08876
Applicant Contact SERGIO J GADALETA
Correspondent
ETHICON INC.
ROUTE 22 WEST
PO BOX 151
SOMERVILLE,  NJ  08876
Correspondent Contact SERGIO J GADALETA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/17/2006
Decision Date 05/25/2006
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
Recalls CDRH Recalls
-
-