510(k) K152183

EXELINT SecureTouch Safety Hypodermic Needle by Exelint International, Co. — Product Code FMI

K152183 is an FDA 510(k) premarket notification submitted by Exelint International, Co. for the device "EXELINT SecureTouch Safety Hypodermic Needle". The FDA issued a decision of Substantially Equivalent on Nov 2, 2015. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Exelint International, Co. has at least 6 other 510(k) clearances on record.