| Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
| 510(k) Number |
K901762 |
| Device Name |
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM |
| 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 | 868.5450 |
| Classification Product Code |
|
| Date Received | 04/18/1990 |
| Decision Date | 07/17/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|