The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Prolite Ultra S Mesh.
| Device ID | K070192 |
| 510k Number | K070192 |
| Device Name: | ATRIUM PROLITE ULTRA 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 | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-03-08 |