The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Ltm-t Surgical Mesh.
| Device ID | K080353 |
| 510k Number | K080353 |
| Device Name: | LTM-T SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Contact | Lorraine T Montemurro |
| Correspondent | Lorraine T Montemurro LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-04-03 |
| Summary: | summary |