Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K002512 |
Device Name |
TORAYSULFONE DIALYZER |
Applicant |
TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. |
BELLAIRE,
TX
77401 -5010
|
|
Applicant Contact |
LISA S JONES |
Correspondent |
TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. |
BELLAIRE,
TX
77401 -5010
|
|
Correspondent Contact |
LISA S JONES |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/15/2000 |
Decision Date | 10/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|