FDA 510(k) Application Details - K081010

Device Classification Name Mesh, Surgical, Polymeric

  More FDA Info for this Device
510(K) Number K081010
Device Name Mesh, Surgical, Polymeric
Applicant DAVOL INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON, RI 02920 US
Other 510(k) Applications for this Company
Contact STEPHANIE BAKER
Other 510(k) Applications for this Contact
Regulation Number 878.3300

  More FDA Info for this Regulation Number
Classification Product Code FTL
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/09/2008
Decision Date 10/07/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact