The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Liteaire.
| Device ID | K993101 |
| 510k Number | K993101 |
| Device Name: | LITEAIRE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 |
| Contact | David T Sladek |
| Correspondent | David T Sladek THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 2000-10-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LITEAIRE 75783220 2610186 Live/Registered |
THAYER MEDICAL CORPORATION 1999-08-24 |