510(k) K082363

COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS by William A. Cook Australia Pty. , Ltd. — Product Code MQL

K082363 is an FDA 510(k) premarket notification submitted by William A. Cook Australia Pty. , Ltd. for the device "COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS". The FDA issued a decision of Substantially Equivalent on April 29, 2009. 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.