510(k) K161950

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMI

K161950 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Promisemed Hangzhou Meditech Co., Ltd. has 35 other 510(k) clearances on record.