510(k) K141749

CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT by Facet Technologies, LLC — Product Code FMI

K141749 is an FDA 510(k) premarket notification submitted by Facet Technologies, LLC for the device "CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT". The FDA issued a decision of Substantially Equivalent on July 29, 2014. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Facet Technologies, LLC has at least 7 other 510(k) clearances on record.