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 K070644
Device Name GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
Applicant
W. L. GORE & ASSOCIATES, INC.
301 AIRPORT RD.
P.O. BOX 1408
ELKTON,  MD  21922 -1408
Applicant Contact BARBARA L SMITH
Correspondent
W. L. GORE & ASSOCIATES, INC.
301 AIRPORT RD.
P.O. BOX 1408
ELKTON,  MD  21922 -1408
Correspondent Contact BARBARA L SMITH
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/08/2007
Decision Date 04/02/2007
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
-
-