The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Lite Mesh.
| Device ID | K002093 |
| 510k Number | K002093 |
| Device Name: | ATRIUM LITE 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 | 2000-07-11 |
| Decision Date | 2000-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862308079 | K002093 | 000 |
| 20650862307140 | K002093 | 000 |
| 20650862307133 | K002093 | 000 |
| 20650862307126 | K002093 | 000 |
| 20650862307119 | K002093 | 000 |
| 20650862307102 | K002093 | 000 |
| 20650862307089 | K002093 | 000 |
| 20650862307058 | K002093 | 000 |
| 20650862307041 | K002093 | 000 |
| 20650862307034 | K002093 | 000 |
| 20650862307027 | K002093 | 000 |
| 20650862307010 | K002093 | 000 |
| 20650862307157 | K002093 | 000 |
| 20650862307171 | K002093 | 000 |
| 20650862307188 | K002093 | 000 |
| 20650862308062 | K002093 | 000 |
| 20650862308055 | K002093 | 000 |
| 20650862308048 | K002093 | 000 |
| 20650862308031 | K002093 | 000 |
| 20650862308024 | K002093 | 000 |
| 20650862308017 | K002093 | 000 |
| 20650862308000 | K002093 | 000 |
| 20650862307225 | K002093 | 000 |
| 20650862307218 | K002093 | 000 |
| 20650862307201 | K002093 | 000 |
| 20650862307195 | K002093 | 000 |
| 20650862307003 | K002093 | 000 |