510(k) K152877

SureFine Pen Needle by Shina Med Corporation — Product Code FMI

K152877 is an FDA 510(k) premarket notification submitted by Shina Med Corporation for the device "SureFine Pen Needle". The FDA issued a decision of Substantially Equivalent on June 7, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Shina Med Corporation has at least 6 other 510(k) clearances on record.