510(k) K080353
K080353 is an FDA 510(k) premarket notification submitted by Lifecell Corp. for the device "LTM-T SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on April 3, 2008. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Lifecell Corp. has at least 9 other 510(k) clearances on record.
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