510(k) K974090

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS by Fresenius Medical Care North America — Product Code MSE

K974090 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS". The FDA issued a decision of Substantially Equivalent on August 27, 1998. The device falls under product code MSE (Hemodialyzer, Re-Use, Low Flux), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.