FDA 510(k) Application Details - K121289

Device Classification Name

  More FDA Info for this Device
510(K) Number K121289
Device Name LTM-LABAROSCOPIC SURGICAL MESH
Applicant LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG, NJ 08876 US
Other 510(k) Applications for this Company
Contact MARK R JAKUBOWSKI
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 04/30/2012
Decision Date 08/03/2012
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