510(k) K211242

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMF

K211242 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes". The FDA issued a decision of Substantially Equivalent on Sep 9, 2021. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Promisemed Hangzhou Meditech Co., Ltd. has 35 other 510(k) clearances on record.