The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Ltm-labaroscopic Surgical Mesh.
| Device ID | K121289 |
| 510k Number | K121289 |
| Device Name: | LTM-LABAROSCOPIC SURGICAL MESH |
| Classification | Mesh, Surgical, Collagen, Large Abdominal Wall Defects |
| Applicant | LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Contact | Mark R Jakubowski |
| Correspondent | Mark R Jakubowski LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Product Code | OXK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-08-03 |
| Summary: | summary |