510(k) K213407

UltiCare Disposable Pen Needles by Ultimed Incorporated — Product Code FMI

K213407 is an FDA 510(k) premarket notification submitted by Ultimed Incorporated for the device "UltiCare Disposable Pen Needles". The FDA issued a decision of Substantially Equivalent on Dec 16, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ultimed Incorporated has 1 other 510(k) clearance on record.