510(k) K133100

CAREFINE PEN NEEDLE by Facet Technologies — Product Code FMI

K133100 is an FDA 510(k) premarket notification submitted by Facet Technologies for the device "CAREFINE PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on January 23, 2014. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Facet Technologies has at least 7 other 510(k) clearances on record.