Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K901301 |
Device Name |
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL |
Applicant |
AUTOMATIC LIQUID PACKAGING, INC. |
2200 W. LAKE SHORE DR. |
WOODSTOCK,
IL
60098
|
|
Applicant Contact |
FRANK LEO |
Correspondent |
AUTOMATIC LIQUID PACKAGING, INC. |
2200 W. LAKE SHORE DR. |
WOODSTOCK,
IL
60098
|
|
Correspondent Contact |
FRANK LEO |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/20/1990 |
Decision Date | 05/31/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|