510(k) K002385

COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, by Cook Ob/Gyn — Product Code MQL

K002385 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,". The FDA issued a decision of Substantially Equivalent on September 18, 2000. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.