510(k) K080353

LTM-T SURGICAL MESH by Lifecell Corp. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2008
Date Received
February 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type