510(k) K190199

SepaSperm Washing Solution, SepaSperm Solution by Kitazato Corporation — Product Code MQL

K190199 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "SepaSperm Washing Solution, SepaSperm Solution". The FDA issued a decision of Substantially Equivalent on September 26, 2019. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Corporation has at least 10 other 510(k) clearances on record.