The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Thayer Expansion Chamber Metered Dose Inhaler.
| Device ID | K914283 |
| 510k Number | K914283 |
| Device Name: | THAYER EXPANSION CHAMBER METERED DOSE INHALER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | THAYER MEDICAL CORP. 4500 EAST SPEEDWAY BLVD. SUITE 20 Tucson, AZ 85712 |
| Contact | David Sladek |
| Correspondent | David Sladek THAYER MEDICAL CORP. 4500 EAST SPEEDWAY BLVD. SUITE 20 Tucson, AZ 85712 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-24 |
| Decision Date | 1992-02-26 |