510(k) K163578

EasyTouch Safety Pen Needle by Mhc Medical Products, LLC — Product Code FMI

K163578 is an FDA 510(k) premarket notification submitted by Mhc Medical Products, LLC for the device "EasyTouch Safety Pen Needle". The FDA issued a decision of Substantially Equivalent on August 3, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Mhc Medical Products, LLC has at least 2 other 510(k) clearances on record.