510(k) K801839

DISPOSABLE HYPODERMIC NEEDLES by Martin'S Maine Exchange — Product Code FMI

K801839 is an FDA 510(k) premarket notification submitted by Martin'S Maine Exchange for the device "DISPOSABLE HYPODERMIC NEEDLES". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Martin'S Maine Exchange has at least 3 other 510(k) clearances on record.