NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) is an FDA 510(k)-cleared medical device (K050827) manufactured by Dialysis Solutions, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2005. Regulation: 8.