510(k) K100988

HUMAPEN LUXURA HD by Eli Lilly and Company — Product Code FMF

K100988 is an FDA 510(k) premarket notification submitted by Eli Lilly and Company for the device "HUMAPEN LUXURA HD". The FDA issued a decision of Substantially Equivalent on August 17, 2010. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Eli Lilly and Company has at least 6 other 510(k) clearances on record.