510(k) K872857

HOSPAL DIALYSATE FOR C.A.V.H.D. by Delmed, Inc. — Product Code KPO

K872857 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "HOSPAL DIALYSATE FOR C.A.V.H.D.". The FDA issued a decision of Substantially Equivalent on October 5, 1987. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Delmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1987
Date Received
July 21, 1987
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