510(k) K060734

FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) by Fresenius Medical Care North America — Product Code LKN

K060734 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)". The FDA issued a decision of Substantially Equivalent on September 5, 2006. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.