510(k) K061371

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER by Cook Urological, Inc. — Product Code MQL

K061371 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "SYDNEY IVF SPERM CRYOPRESERVATION BUFFER". The FDA issued a decision of Substantially Equivalent on August 17, 2006. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.