| Device Classification Name |
Subsystem, Water Purification
|
| 510(k) Number |
K934848 |
| Device Name |
MASTER ALERT |
| Applicant |
| Master Hydro Systems, Inc. |
| 4500 S. Broadway |
|
Wichita,
KS
67216
|
|
| Applicant Contact |
J. M. GREENING |
| Correspondent |
| Master Hydro Systems, Inc. |
| 4500 S. Broadway |
|
Wichita,
KS
67216
|
|
| Correspondent Contact |
J. M. GREENING |
| Regulation Number | 876.5665 |
| Classification Product Code |
|
| Date Received | 10/21/1993 |
| Decision Date | 09/29/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|