Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K883748 |
Device Name |
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS |
Applicant |
KAWASUMI LABORATORIES CO., LTD. |
KAWASUMI BLDG. 3-28-15 |
MINAMI-OHI, SHINAGAWA-KU |
TOKYO,
JP
140
|
|
Applicant Contact |
KENJIRO TANI |
Correspondent |
KAWASUMI LABORATORIES CO., LTD. |
KAWASUMI BLDG. 3-28-15 |
MINAMI-OHI, SHINAGAWA-KU |
TOKYO,
JP
140
|
|
Correspondent Contact |
KENJIRO TANI |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/01/1988 |
Decision Date | 01/31/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|