Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K041884 |
Device Name |
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
Applicant |
MUELLER WATER CONDITIONING, INC. |
1500 SHERWOOD FOREST DR. |
HOUSTON,
TX
77043 -3899
|
|
Applicant Contact |
DAVID W MUELLER |
Correspondent |
MUELLER WATER CONDITIONING, INC. |
1500 SHERWOOD FOREST DR. |
HOUSTON,
TX
77043 -3899
|
|
Correspondent Contact |
DAVID W MUELLER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 07/12/2004 |
Decision Date | 02/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|