510(k) K823068

MEDISYSTEMS FISTULA NEEDLES by Medisystems Corp. — Product Code KOC

K823068 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "MEDISYSTEMS FISTULA NEEDLES". The FDA issued a decision of Substantially Equivalent on January 26, 1983. 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.