510(k) K961706

P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR by Fresenius USA, Inc. — Product Code LKN

K961706 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR". The FDA issued a decision of Substantially Equivalent on July 31, 1996. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.