The following data is part of a premarket notification filed by Thayer Medical Corporation with the FDA for Thayer Medical Liteaire Dual-valved, Collapsible Mdi Holding Chamber.
| Device ID | K160109 |
| 510k Number | K160109 |
| Device Name: | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | THAYER MEDICAL CORPORATION 4575 SOUTH PALO VERDE ROAD SUITE 337 Tucson, AZ 85714 |
| Contact | Meghan Mcgovern |
| Correspondent | Jennifer Lh Johnson THAYER MEDICAL CORPORATION 4575 SOUTH PALO VERDE ROAD SUITE 337 Tucson, AZ 85714 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2017-05-19 |
| Summary: | summary |