510(k) K944866

VIASPAN (BELZER UW - CSS) by The Dupont Merck Pharmaceutical Co. — Product Code KDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1996
Date Received
October 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type