510(k) K150950

FreezeKit Cleave , ThawKit Cleave by Vitrolife Sweden AB — Product Code MQL

K150950 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "FreezeKit Cleave , ThawKit Cleave". The FDA issued a decision of Substantially Equivalent on December 21, 2015. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.