The following data is part of a premarket notification filed by Medel S.p.a. with the FDA for Ag-classic.
| Device ID | K072494 |
| 510k Number | K072494 |
| Device Name: | AG-CLASSIC |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDEL S.P.A. 112 CAVISTION WAY Cary, NC 27519 |
| Contact | Terrance M O'brien |
| Correspondent | Terrance M O'brien MEDEL S.P.A. 112 CAVISTION WAY Cary, NC 27519 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-05 |
| Decision Date | 2008-02-12 |