510(k) K080235

SAFETY INFUSION SET by Greiner Bio-One Vacuette North America — Product Code FMI

K080235 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Vacuette North America for the device "SAFETY INFUSION SET". The FDA issued a decision of Substantially Equivalent on April 24, 2008. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Greiner Bio-One Vacuette North America has at least 4 other 510(k) clearances on record.