510(k) K100367

MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 by Origio A/S — Product Code MQL

K100367 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Origio A/S has at least 10 other 510(k) clearances on record.