510(k) K180545

VACUETTE SAFELINK Holder with male luer lock by Greiner Bio-One Na, Inc. — Product Code FMI

K180545 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Na, Inc. for the device "VACUETTE SAFELINK Holder with male luer lock". The FDA issued a decision of Substantially Equivalent on May 21, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Greiner Bio-One Na, Inc. has 4 other 510(k) clearances on record.