510(k) K192222

EZ-Inject Single use Needle by Poonglim Pharmatech, Inc. — Product Code FMI

K192222 is an FDA 510(k) premarket notification submitted by Poonglim Pharmatech, Inc. for the device "EZ-Inject Single use Needle". The FDA issued a decision of Substantially Equivalent on May 12, 2020. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Poonglim Pharmatech, Inc. has at least 5 other 510(k) clearances on record.