Device Classification Name |
Holding Chambers, Direct Patient Interface
|
510(k) Number |
K160109 |
Device Name |
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber |
Applicant |
THAYER MEDICAL CORPORATION |
4575 SOUTH PALO VERDE ROAD |
SUITE 337 |
TUCSON,
AZ
85714
|
|
Applicant Contact |
MEGHAN MCGOVERN |
Correspondent |
THAYER MEDICAL CORPORATION |
4575 SOUTH PALO VERDE ROAD |
SUITE 337 |
TUCSON,
AZ
85714
|
|
Correspondent Contact |
JENNIFER LH JOHNSON |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 01/19/2016 |
Decision Date | 05/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|