510(k) K841124

DIALYSIS TRAY by Medcare Products — Product Code KOC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1984
Date Received
March 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type