510(k) K212207

Sterile Hypodermic Syringe for Single Use by Shandong Weigao Group Medical Polymer Co., Ltd. — Product Code FMF

K212207 is an FDA 510(k) premarket notification submitted by Shandong Weigao Group Medical Polymer Co., Ltd. for the device "Sterile Hypodermic Syringe for Single Use". The FDA issued a decision of Substantially Equivalent on Mar 23, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Shandong Weigao Group Medical Polymer Co., Ltd. has 6 other 510(k) clearances on record.