The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Prolite S Mesh.
| Device ID | K082748 |
| 510k Number | K082748 |
| Device Name: | ATRIUM PROLITE S 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 | Yes |
| Date Received | 2008-09-19 |
| Decision Date | 2009-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650862313888 | K082748 | 000 |
| 20650862313127 | K082748 | 000 |
| 00650862313222 | K082748 | 000 |
| 00650862313246 | K082748 | 000 |
| 00650862313260 | K082748 | 000 |
| 00650862313284 | K082748 | 000 |
| 00650862313321 | K082748 | 000 |
| 00650862313369 | K082748 | 000 |
| 00650862313406 | K082748 | 000 |
| 00650862313413 | K082748 | 000 |
| 00650862313420 | K082748 | 000 |
| 00650862313857 | K082748 | 000 |
| 20650862313110 | K082748 | 000 |