510(k) K951515

MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER by Sherwood Medical Co. — Product Code FMI

K951515 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.