The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for C-qur V -patch Mesh.
| Device ID | K090909 |
| 510k Number | K090909 |
| Device Name: | C-QUR V -PATCH 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862312027 | K090909 | 000 |
| 00650862312010 | K090909 | 000 |
| 00650862312003 | K090909 | 000 |