The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for C-qur Rpm Mesh.
| Device ID | K121070 |
| 510k Number | K121070 |
| Device Name: | C-QUR RPM MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
| Contact | Joseph Depaolo |
| Correspondent | Joseph Depaolo ATRIUM MEDICAL CORP. 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 | 2012-04-09 |
| Decision Date | 2012-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862311440 | K121070 | 000 |
| 00650862311068 | K121070 | 000 |
| 00650862311075 | K121070 | 000 |
| 00650862311266 | K121070 | 000 |
| 00650862311273 | K121070 | 000 |
| 00650862311280 | K121070 | 000 |
| 00650862311310 | K121070 | 000 |
| 00650862311334 | K121070 | 000 |
| 00650862311341 | K121070 | 000 |
| 00650862311358 | K121070 | 000 |
| 00650862311365 | K121070 | 000 |
| 00650862311372 | K121070 | 000 |
| 00650862311389 | K121070 | 000 |
| 00650862311402 | K121070 | 000 |
| 00650862311426 | K121070 | 000 |
| 00650862311433 | K121070 | 000 |
| 00650862311051 | K121070 | 000 |