510(k) K211716

DropSafe Safety Pen Needles by Htl Strefa SA — Product Code FMI

K211716 is an FDA 510(k) premarket notification submitted by Htl Strefa SA for the device "DropSafe Safety Pen Needles". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.