510(k) K151311

Safe Block Pen Needle by Artsana S.P.A — Product Code FMI

K151311 is an FDA 510(k) premarket notification submitted by Artsana S.P.A for the device "Safe Block Pen Needle". The FDA issued a decision of Substantially Equivalent on Feb 10, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Artsana S.P.A has 2 other 510(k) clearances on record.