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
510(k) Number K021107
Device Name FORTAFLEX SURGICAL SLING
Applicant
ORGANOGENESIS, INC.
150 DAN RD.
CANTON,  MA  02021
Applicant Contact MICHAEL L SABOLINSKI
Correspondent
ORGANOGENESIS, INC.
150 DAN RD.
CANTON,  MA  02021
Correspondent Contact MICHAEL L SABOLINSKI
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/05/2002
Decision Date 05/15/2002
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
-
-