510(k) K871583

MODIFIED LABELING FOR AMUKIN-50% by Amuchina Intl., Inc. — Product Code KDJ

K871583 is an FDA 510(k) premarket notification submitted by Amuchina Intl., Inc. for the device "MODIFIED LABELING FOR AMUKIN-50%". The FDA issued a decision of Substantially Equivalent on July 9, 1987. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Amuchina Intl., Inc. has at least 4 other 510(k) clearances on record.