510(k) K093109

NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') by Novo Nordisk, Inc. — Product Code FMI

K093109 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')". The FDA issued a decision of Substantially Equivalent on June 18, 2010. 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.