510(k) K113786

SPERMFREEZE SOLUTION by Vitrolife Sweden AB — Product Code MQL

K113786 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "SPERMFREEZE SOLUTION". The FDA issued a decision of Substantially Equivalent on October 26, 2012. 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.