The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Ltm-perforated Surgical Mesh.
| Device ID | K150712 |
| 510k Number | K150712 |
| Device Name: | LTM-Perforated Surgical Mesh |
| Classification | Mesh, Surgical |
| Applicant | LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
| Contact | Linda Scamardella |
| Correspondent | Linda Scamardella LifeCell Corporation One Millennium Way Branchburg, NJ 08876 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-19 |
| Decision Date | 2015-07-02 |
| Summary: | summary |