Device Classification Name |
subsystem, water purification
|
510(k) Number |
K980182 |
Device Name |
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
Applicant |
U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. |
LOWELL,
MA
01851
|
|
Applicant Contact |
CHERYL ARDIZZONI |
Correspondent |
U.S. FILTER/IONPURE, INC. |
10 TECHNOLOGY DR. |
LOWELL,
MA
01851
|
|
Correspondent Contact |
CHERYL ARDIZZONI |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 01/20/1998 |
Decision Date | 11/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|