Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K891477 |
Device Name |
CLIRANS HOLLOW FIBER HEMODIALYZER (WET) |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GEORGE S MOMODA |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GEORGE S MOMODA |
Regulation Number | 876.5820 |
Classification Product Code |
|
Date Received | 03/16/1989 |
Decision Date | 06/09/1989 |
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
|
|
|