Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K873516 |
Device Name |
KAWASUMI BLOOD TUBING LINE |
Applicant |
KAWASUMI LABORATORIES CO., LTD. |
21515 VANOWEN ST., NO. 101 |
CANOGA PARK,
CA
91303
|
|
Applicant Contact |
MARK A O'BRIEN |
Correspondent |
KAWASUMI LABORATORIES CO., LTD. |
21515 VANOWEN ST., NO. 101 |
CANOGA PARK,
CA
91303
|
|
Correspondent Contact |
MARK A O'BRIEN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/31/1987 |
Decision Date | 10/05/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|