510(k) K191531

Sure-Fine Insulin Syringes by Shina Med Corporation — Product Code FMF

K191531 is an FDA 510(k) premarket notification submitted by Shina Med Corporation for the device "Sure-Fine Insulin Syringes". The FDA issued a decision of Substantially Equivalent on September 6, 2019. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Shina Med Corporation has at least 6 other 510(k) clearances on record.