510(k) K191643

TK Sterile Hypodermic Needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FMI

K191643 is an FDA 510(k) premarket notification submitted by Anhui Tiankang Medical Technology Co., Ltd. for the device "TK Sterile Hypodermic Needle". The FDA issued a decision of Substantially Equivalent on December 19, 2019. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Anhui Tiankang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.