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 Collagen Surgical Mesh Containing Drugs
510(k) Number K151177
Device Name XenMatrix AB Surgical Graft
Applicant
C. R. Bard
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact Tony John
Correspondent
C. R. Bard
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact Tony John
Regulation Number878.3300
Classification Product Code
PIJ  
Subsequent Product Codes
FTM   OXH  
Date Received05/01/2015
Decision Date 07/30/2015
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 Yes
Predetermined Change
Control Plan Authorized		 No
-
-