The following data is part of a premarket notification filed by Atrium Medical Corporation with the FDA for Atrium Centrilfx Mesh.
| Device ID | K110110 |
| 510k Number | K110110 |
| Device Name: | ATRIUM CENTRILFX MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORPORATION 5 WENTWORTH DR Hudson, NH 03051 |
| Contact | Raymond J Kelly |
| Correspondent | Raymond J Kelly ATRIUM MEDICAL CORPORATION 5 WENTWORTH DR Hudson, NH 03051 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-14 |
| Decision Date | 2011-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862313970 | K110110 | 000 |
| 00650862313963 | K110110 | 000 |
| 00650862313956 | K110110 | 000 |