510(k) K133738

NOVOFINE PLUS 32G 4 MM by Novo Nordisk, Inc. — Product Code FMI

K133738 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NOVOFINE PLUS 32G 4 MM". The FDA issued a decision of Substantially Equivalent on May 21, 2014. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Novo Nordisk, Inc. has at least 10 other 510(k) clearances on record.