510(k) K862928

AMUKIN-50% FOR CAPD Y-SET by Amuchina Intl., Inc. — Product Code FKX

K862928 is an FDA 510(k) premarket notification submitted by Amuchina Intl., Inc. for the device "AMUKIN-50% FOR CAPD Y-SET". The FDA issued a decision of Substantially Equivalent on March 9, 1987. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Amuchina Intl., Inc. has at least 4 other 510(k) clearances on record.