510(k) K082727

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN by Vitrolife Sweden AB — Product Code MQE

K082727 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.