Device Classification Name |
Set, Perfusion, Kidney, Disposable
|
510(k) Number |
K900492 |
Device Name |
LABELING CHANGE - VIASPAN(TM) (BELZER UW) |
Applicant |
THE DU PONT CO. |
CHESTNUT RUN PLAZA |
P.O. BOX 80715 |
WILMINGTON,
DE
|
|
Applicant Contact |
ANN M GRUMET |
Correspondent |
THE DU PONT CO. |
CHESTNUT RUN PLAZA |
P.O. BOX 80715 |
WILMINGTON,
DE
|
|
Correspondent Contact |
ANN M GRUMET |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 02/02/1990 |
Decision Date | 03/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|