HEMODIALYSIS CONCENTRATE SOLUTION

HEMODIALYSIS CONCENTRATE SOLUTION is an FDA 510(k)-cleared medical device (K792513) manufactured by Mid Atlantic Nephrology Center. 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 April 7, 1980. Regulation: 8.