DBB-05 HEMODIALYSIS DELIVERY SYSTEM

DBB-05 HEMODIALYSIS DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K023509) manufactured by Davita Clinical Research (Trri). 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 October 29, 2003. Regulation: 8.