510(k) K861156

HOSPAL DIALYSATE FOR CAVHD by Hospal Medical Corp. — Product Code KPO

K861156 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "HOSPAL DIALYSATE FOR CAVHD". The FDA issued a decision of Substantially Equivalent on September 23, 1986. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1986
Date Received
March 28, 1986
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