The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation C-qur Mesh.
| Device ID | K050311 |
| 510k Number | K050311 |
| Device Name: | ATRIUM MEDICAL CORPORATION C-QUR MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P De Paolo |
| Correspondent | Joseph P De Paolo ATRIUM MEDICAL CORP. 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 | 2005-02-08 |
| Decision Date | 2006-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862315912 | K050311 | 000 |
| 00650862315066 | K050311 | 000 |
| 00650862315073 | K050311 | 000 |
| 00650862315264 | K050311 | 000 |
| 00650862315271 | K050311 | 000 |
| 00650862315288 | K050311 | 000 |
| 00650862315318 | K050311 | 000 |
| 00650862315332 | K050311 | 000 |
| 00650862315349 | K050311 | 000 |
| 00650862315356 | K050311 | 000 |
| 00650862315363 | K050311 | 000 |
| 00650862315370 | K050311 | 000 |
| 00650862315387 | K050311 | 000 |
| 00650862315400 | K050311 | 000 |
| 00650862315424 | K050311 | 000 |
| 00650862315431 | K050311 | 000 |
| 00650862315448 | K050311 | 000 |
| 00650862315059 | K050311 | 000 |