510(k) K061483

VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES by Greiner Bio-One North America, Inc. — Product Code FMI

K061483 is an FDA 510(k) premarket notification submitted by Greiner Bio-One North America, Inc. for the device "VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES". The FDA issued a decision of Substantially Equivalent on August 14, 2006. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Greiner Bio-One North America, Inc. has at least 9 other 510(k) clearances on record.