510(k) K121908

SAFETY INFUSION SET by Greiner Bio-One North America, Inc. — Product Code FMI

K121908 is an FDA 510(k) premarket notification submitted by Greiner Bio-One North America, Inc. for the device "SAFETY INFUSION SET". The FDA issued a decision of Substantially Equivalent on July 25, 2012. 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.