510(k) K830183

ASAHI HOLLOW FIBER KIDNEYS NR SERIES by Advocacy International, Ltd. — Product Code KOC

K830183 is an FDA 510(k) premarket notification submitted by Advocacy International, Ltd. for the device "ASAHI HOLLOW FIBER KIDNEYS NR SERIES". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Advocacy International, Ltd. has at least 10 other 510(k) clearances on record.