510(k) K180259

Sterile Hypodermic Needle for Single Use by Jiangsu Shenli Medical Production Co., Ltd. — Product Code FMI

K180259 is an FDA 510(k) premarket notification submitted by Jiangsu Shenli Medical Production Co., Ltd. for the device "Sterile Hypodermic Needle for Single Use". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Jiangsu Shenli Medical Production Co., Ltd. has at least 2 other 510(k) clearances on record.