Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K914283 |
Device Name |
THAYER EXPANSION CHAMBER METERED DOSE INHALER |
Applicant |
THAYER MEDICAL CORP. |
4500 EAST SPEEDWAY BLVD. |
SUITE 20 |
TUCSON,
AZ
85712
|
|
Applicant Contact |
DAVID SLADEK |
Correspondent |
THAYER MEDICAL CORP. |
4500 EAST SPEEDWAY BLVD. |
SUITE 20 |
TUCSON,
AZ
85712
|
|
Correspondent Contact |
DAVID SLADEK |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/24/1991 |
Decision Date | 02/26/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|