510(k) K160199

Advocate Insulin Pen Needles by Diabetic Supply of Suncoast, Inc. — Product Code FMI

K160199 is an FDA 510(k) premarket notification submitted by Diabetic Supply of Suncoast, Inc. for the device "Advocate Insulin Pen Needles". The FDA issued a decision of Substantially Equivalent on October 19, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.