B. BRAUN MODIFIED BICARBONATE DIALYSATE

B. BRAUN MODIFIED BICARBONATE DIALYSATE is an FDA 510(k)-cleared medical device (K052393) manufactured by B.Braun Medical, 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 November 8, 2005. Regulation: 8.