510(k) K212949

Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use by Henan Nursecare Biotechnology Co., Ltd. — Product Code MEG

K212949 is an FDA 510(k) premarket notification submitted by Henan Nursecare Biotechnology Co., Ltd. for the device "Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use". The FDA issued a decision of Substantially Equivalent on February 24, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860.