Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K850655 |
Device Name |
TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 |
Applicant |
ERIKA, INC. |
ONE ERIKA PLAZA |
ROCKLEIGH,
NJ
07647
|
|
Applicant Contact |
DEL DONNA |
Correspondent |
ERIKA, INC. |
ONE ERIKA PLAZA |
ROCKLEIGH,
NJ
07647
|
|
Correspondent Contact |
DEL DONNA |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 02/19/1985 |
Decision Date | 03/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|