510(k) K191639

TK Insulin Syringe with/without Saftey Retractable Device by Anhui Tiankang Medical Technology Co., Ltd. — Product Code MEG

K191639 is an FDA 510(k) premarket notification submitted by Anhui Tiankang Medical Technology Co., Ltd. for the device "TK Insulin Syringe with/without Saftey Retractable Device". The FDA issued a decision of Substantially Equivalent on September 11, 2020. The device falls under product code MEG (Syringe, Antistick), 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.