510(k) K190183

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code MEG

K190183 is an FDA 510(k) premarket notification submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. for the device "Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe". The FDA issued a decision of Substantially Equivalent on October 4, 2019. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has at least 10 other 510(k) clearances on record.