510(k) K060333

DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM by Dialysis Services, Inc. — Product Code FIN

K060333 is an FDA 510(k) premarket notification submitted by Dialysis Services, Inc. for the device "DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 2006. The device falls under product code FIN (Tank, Holding, Dialysis), a Class II device regulated under 21 CFR 876.5820. Dialysis Services, Inc. has at least 1 other 510(k) clearance on record.