510(k) K051783

ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES by Artsana S.P.A — Product Code FMI

K051783 is an FDA 510(k) premarket notification submitted by Artsana S.P.A for the device "ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES". The FDA issued a decision of Substantially Equivalent on Oct 4, 2005. 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.