The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Polypropylene Mesh.
| Device ID | K930669 |
| 510k Number | K930669 |
| Device Name: | ATRIUM POLYPROPYLENE MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Contact | Ted Karwoski |
| Correspondent | Ted Karwoski ATRIUM MEDICAL CORP. 17 CLINTON DR. Hollis, NH 03049 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-11 |
| Decision Date | 1993-12-16 |