510(k) K952518

SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE by Medi-Dose, Inc. — Product Code FMI

K952518 is an FDA 510(k) premarket notification submitted by Medi-Dose, Inc. for the device "SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE". The FDA issued a decision of Substantially Equivalent on Jul 28, 1995. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Medi-Dose, Inc. has at least 3 other 510(k) clearances on record.