FDA 510(k) Application Details - K031925

Device Classification Name Mesh, Surgical, Polymeric

  More FDA Info for this Device
510(K) Number K031925
Device Name Mesh, Surgical, Polymeric
Applicant ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE, NJ 08876 US
Other 510(k) Applications for this Company
Contact REY LIBROJO
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 06/23/2003
Decision Date 09/17/2003
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