510(k) K844305

GAINOR MEDICAL FLOWMAX NEEDLES by Gainor Medical — Product Code FMI

K844305 is an FDA 510(k) premarket notification submitted by Gainor Medical for the device "GAINOR MEDICAL FLOWMAX NEEDLES". The FDA issued a decision of Substantially Equivalent on November 30, 1984. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Gainor Medical has at least 10 other 510(k) clearances on record.