510(k) K080446

RAPIDVIT AND RAPIDWARM CLEAVE by Vitrolife Sweden AB — Product Code MQL

K080446 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "RAPIDVIT AND RAPIDWARM CLEAVE". The FDA issued a decision of Substantially Equivalent on November 26, 2008. 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.