SERIM DISINTEK GTA 2.1%, MODEL: 5164

SERIM DISINTEK GTA 2.1%, MODEL: 5164 is an FDA 510(k)-cleared medical device (K083295) manufactured by Serim Research Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2009. Regulation: 8.