510(k) K971860

MEDISYSTEMS DIALYSIS PRIMING SETS by Medisystems Corp. — Product Code KOC

K971860 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "MEDISYSTEMS DIALYSIS PRIMING SETS". The FDA issued a decision of Substantially Equivalent on August 18, 1997. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Medisystems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
May 20, 1997
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