Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K882158 |
Device Name |
MODIFIED TORAY FILTRYZER DIALYZERS |
Applicant |
TORAY INDUSTRIES (AMERICA), INC. |
280 PARK AVE. |
NEW YORK,
NY
10017
|
|
Applicant Contact |
KOHKI UENO |
Correspondent |
TORAY INDUSTRIES (AMERICA), INC. |
280 PARK AVE. |
NEW YORK,
NY
10017
|
|
Correspondent Contact |
KOHKI UENO |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/23/1988 |
Decision Date | 08/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|