510(k) K180720

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel by Medibio USA, LLC — Product Code FMI

K180720 is an FDA 510(k) premarket notification submitted by Medibio USA, LLC for the device "Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel". The FDA issued a decision of Substantially Equivalent on Jun 27, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.