510(k) K160814

Sydney IVF Sperm Cryopreservation Buffer by William A. Cook Australia Pty. , Ltd. — Product Code MQL

K160814 is an FDA 510(k) premarket notification submitted by William A. Cook Australia Pty. , Ltd. for the device "Sydney IVF Sperm Cryopreservation Buffer". The FDA issued a decision of Substantially Equivalent on April 22, 2016. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. William A. Cook Australia Pty. , Ltd. has at least 10 other 510(k) clearances on record.