The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium C-qur Ovt Mesh.
| Device ID | K100076 |
| 510k Number | K100076 |
| Device Name: | ATRIUM C-QUR OVT MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Jacqueline Emery |
| Correspondent | Jacqueline Emery 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 | 2010-01-12 |
| Decision Date | 2010-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862316445 | K100076 | 000 |
| 00650862316117 | K100076 | 000 |
| 00650862316124 | K100076 | 000 |
| 00650862316261 | K100076 | 000 |
| 00650862316285 | K100076 | 000 |
| 00650862316339 | K100076 | 000 |
| 00650862316360 | K100076 | 000 |
| 00650862316377 | K100076 | 000 |
| 00650862316384 | K100076 | 000 |
| 00650862316100 | K100076 | 000 |