510(k) K162716

bibag by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KPO

K162716 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "bibag". The FDA issued a decision of Substantially Equivalent on May 18, 2017. 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 Renal Therapies Group, LLC has 51 other 510(k) clearances on record.