510(k) K053551

MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL by <Genx> Intl., Inc. — Product Code MQL

K053551 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL". The FDA issued a decision of Substantially Equivalent on May 9, 2006. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. <Genx> Intl., Inc. has at least 10 other 510(k) clearances on record.