The following data is part of a premarket notification filed by Atrium Medical Corporation with the FDA for C-qur, C-qur Fx, C-qur Tacshield, C-qur V-patch, C-qur Centrifx, C-qur Mosaic.
| Device ID | K151386 |
| 510k Number | K151386 |
| Device Name: | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORPORATION 5 WENTWORTH DR Hudson, NH 03051 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott ATRIUM MEDICAL CORPORATION 5 WENTWORTH DR Hudson, NH 03051 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-10-22 |
| Summary: | summary |