| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|