510(k) K191642

TK Sterile Piston Syringe without Needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FMF

K191642 is an FDA 510(k) premarket notification submitted by Anhui Tiankang Medical Technology Co., Ltd. for the device "TK Sterile Piston Syringe without Needle". The FDA issued a decision of Substantially Equivalent on January 6, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Anhui Tiankang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.