510(k) K883068

HEMODIALYSIS CONCENTRATES by Dove Medical Supplies — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1988
Date Received
July 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type