Device Classification Name |
set, tubing, blood, with and without anti-regurgitation valve
|
510(k) Number |
K896407 |
Device Name |
HAEMOTRONIC BLOOD LINE SET |
Applicant |
HEALTHCARE SUPPLIERS, INC. |
3925 W. NORTHSIDE DR. |
JACKSON,
MS
39209
|
|
Applicant Contact |
JOHN O WILLIAMS |
Correspondent |
HEALTHCARE SUPPLIERS, INC. |
3925 W. NORTHSIDE DR. |
JACKSON,
MS
39209
|
|
Correspondent Contact |
JOHN O WILLIAMS |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 11/07/1989 |
Decision Date | 04/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|