The following data is part of a premarket notification filed by Lifecell Corporation with the FDA for Artia Reconstructive Tissue Matrix Perforated.
| Device ID | K162752 |
| 510k Number | K162752 |
| Device Name: | ARTIA Reconstructive Tissue Matrix Perforated |
| Classification | Mesh, Surgical |
| Applicant | LIFECELL CORPORATION ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Contact | Anuja Yardi |
| Correspondent | Anuja Yardi 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 | 2016-09-30 |
| Decision Date | 2017-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M328CXL1097P0 | K162752 | 000 |
| M328CS1097P0 | K162752 | 000 |
| M328CM1097P0 | K162752 | 000 |
| M328CL1097P0 | K162752 | 000 |
| M32816201097P0 | K162752 | 000 |