• 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 K082687
Device Name COLLAMEND FM IMPLANT
Applicant
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact KEVIN G STEVENS
Correspondent
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact KEVIN G STEVENS
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/15/2008
Decision Date 10/17/2008
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
-
-