Device Classification Name |
set, perfusion, kidney, disposable
|
510(k) Number |
K944866 |
Device Name |
VIASPAN (BELZER UW - CSS) |
Applicant |
THE DUPONT MERCK PHARMACEUTICAL CO. |
EXPERIMENTAL STATION BLDG. 353 |
WILMINGTON,
DE
19880 -0353
|
|
Applicant Contact |
JAMES L GASKILL |
Correspondent |
THE DUPONT MERCK PHARMACEUTICAL CO. |
EXPERIMENTAL STATION BLDG. 353 |
WILMINGTON,
DE
19880 -0353
|
|
Correspondent Contact |
JAMES L GASKILL |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 10/03/1994 |
Decision Date | 04/22/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|