510(k) K050106

NOVOFINE AUTOCOVER 30G X 8MM by Novo Nordisk, Inc. — Product Code FMI

K050106 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NOVOFINE AUTOCOVER 30G X 8MM". The FDA issued a decision of Substantially Equivalent on March 30, 2005. 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.