WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE is an FDA 510(k)-cleared medical device (K110615) manufactured by Bebe Toys Manufactory , Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2011. Regulation: 8.