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 K083039
Device Name VERITAS COLLAGEN MATRIX (DRY)
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL,  MN  55114 -1024
Applicant Contact JODI JORGENSON
Correspondent
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL,  MN  55114 -1024
Correspondent Contact JODI JORGENSON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received10/14/2008
Decision Date 11/26/2008
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
-
-