HEMODIALYSIS BATH CONCENTRATE SOLUTION

HEMODIALYSIS BATH CONCENTRATE SOLUTION is an FDA 510(k)-cleared medical device (K842058) manufactured by Pharmaceutical Development Systems. 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 July 25, 1984. Regulation: 8.