About This 510(k) Submission
K120333 is an FDA 510(k) clearance for the PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Gambro Renal Products (Daytona Beach, US). The FDA issued a Cleared decision on May 25, 2012, 112 days after receiving the submission on February 3, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.