510(k) K053494

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE by Fertipro NV — Product Code MQL

K053494 is an FDA 510(k) premarket notification submitted by Fertipro NV for the device "OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE". The FDA issued a decision of Substantially Equivalent on March 23, 2006. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Fertipro NV has at least 3 other 510(k) clearances on record.