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 |