Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K944385 |
Device Name |
MD400 A/B/C/D/E/F/G |
Applicant |
INTERNATIONAL PURIFICATION SYSTEMS, INC. |
2520 RIDGEMAR COURT |
LOUISVILLE,
KY
40299
|
|
Applicant Contact |
RONALD L WATHEN |
Correspondent |
INTERNATIONAL PURIFICATION SYSTEMS, INC. |
2520 RIDGEMAR COURT |
LOUISVILLE,
KY
40299
|
|
Correspondent Contact |
RONALD L WATHEN |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 09/07/1994 |
Decision Date | 04/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|