510(k) K970700

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX by Fresenius USA, Inc. — Product Code MSE

K970700 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX". The FDA issued a decision of Substantially Equivalent on September 15, 1998. The device falls under product code MSE (Hemodialyzer, Re-Use, Low Flux), a Class II device regulated under 21 CFR 876.5820. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.