510(k) K941867

RENALIN REUSE CART by Renal Scientific Service, Inc. — Product Code LIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1996
Date Received
April 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type