510(k) K171144

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel by Medbio, LLC — Product Code FMI

K171144 is an FDA 510(k) premarket notification submitted by Medbio, LLC for the device "Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel". The FDA issued a decision of Substantially Equivalent on Sep 12, 2017. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.