The following data is part of a premarket notification filed by Tri/bor Medical, Inc. with the FDA for Aero-gen Nubulizer System.
| Device ID | K904718 |
| 510k Number | K904718 |
| Device Name: | AERO-GEN NUBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRI/BOR MEDICAL, INC. P.O. BOX 419 Westtown, NY 10998 |
| Contact | Kathleen Miressi |
| Correspondent | Kathleen Miressi TRI/BOR MEDICAL, INC. P.O. BOX 419 Westtown, NY 10998 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-18 |
| Decision Date | 1991-04-01 |