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 K081010
FOIA Releasable 510(k) K081010
Device Name BARD 3DMAX MESH
Applicant
DAVOL INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact STEPHANIE BAKER
Correspondent
DAVOL INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Correspondent Contact STEPHANIE BAKER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/09/2008
Decision Date 10/07/2008
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
-
-