510(k) K792174

MODEL DM 353 & DM-353-L SINGLE NEEDLE by Extracorporeal Medical Specialities, Inc. — Product Code FIF

K792174 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "MODEL DM 353 & DM-353-L SINGLE NEEDLE". The FDA issued a decision of Substantially Equivalent on November 16, 1979. The device falls under product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.