510(k) K210227

Sterile syringe for single use with/without needle by Zhejiang Kangkang Medical-Devices Co., Ltd. — Product Code FMF

K210227 is an FDA 510(k) premarket notification submitted by Zhejiang Kangkang Medical-Devices Co., Ltd. for the device "Sterile syringe for single use with/without needle". The FDA issued a decision of Substantially Equivalent on September 10, 2021. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Zhejiang Kangkang Medical-Devices Co., Ltd. has at least 3 other 510(k) clearances on record.