The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Ltn - Laparoscopic Surgical Mesh.
| Device ID | K130817 |
| 510k Number | K130817 |
| Device Name: | LTN - LAPAROSCOPIC SURGICAL MESH |
| Classification | Mesh, Surgical, Collagen, Large Abdominal Wall Defects |
| Applicant | LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Contact | John Blewitt |
| Correspondent | John Blewitt LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Product Code | OXK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-04-17 |
| Summary: | summary |