Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K934803 |
Device Name |
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS |
Applicant |
BAXTER HEALTHCARE CORP. |
1620 WAULKEGAN RD. |
MCGAW PARK,
IL
60085 -6730
|
|
Applicant Contact |
ROBERT L WILKINSON |
Correspondent |
BAXTER HEALTHCARE CORP. |
1620 WAULKEGAN RD. |
MCGAW PARK,
IL
60085 -6730
|
|
Correspondent Contact |
ROBERT L WILKINSON |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 10/20/1993 |
Decision Date | 12/17/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|