510(k) K002180

SIMPLICITY DISPOSABLE PEN NEEDLE by Sterling Medivations, Inc. — Product Code FMI

K002180 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY DISPOSABLE PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on Oct 13, 2000. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.