510(k) K010359

INNOVO by Novo Nordisk A/S — Product Code FMF

K010359 is an FDA 510(k) premarket notification submitted by Novo Nordisk A/S for the device "INNOVO". The FDA issued a decision of Substantially Equivalent on March 14, 2001. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Novo Nordisk A/S has at least 10 other 510(k) clearances on record.