510(k) K190002

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use by Shanghai Kohope Medical Devices Co., Ltd. — Product Code FMF

K190002 is an FDA 510(k) premarket notification submitted by Shanghai Kohope Medical Devices Co., Ltd. for the device "Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use". The FDA issued a decision of Substantially Equivalent on Sep 12, 2019. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.