Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K884359 |
Device Name |
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA. |
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 | 10/17/1988 |
Decision Date | 12/20/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|