510(k) K030497

FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES by Fresenius Medical Care — Product Code KPO

K030497 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care for the device "FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES". The FDA issued a decision of Substantially Equivalent on May 20, 2003. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care has at least 6 other 510(k) clearances on record.