510(k) K192082

Droplet Pen Needle 34G by Htl-Strefa S.A — Product Code FMI

K192082 is an FDA 510(k) premarket notification submitted by Htl-Strefa S.A for the device "Droplet Pen Needle 34G". The FDA issued a decision of Substantially Equivalent on April 21, 2020. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Htl-Strefa S.A has at least 6 other 510(k) clearances on record.