VIVONEX TUNG STEN TIP TUBE

VIVONEX TUNG STEN TIP TUBE is an FDA 510(k)-cleared medical device (K842841) manufactured by Norwich Eaton Pharmaceuticals, 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 August 13, 1984. Regulation: 8.