EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)

EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) is an FDA 510(k)-cleared medical device (K050495) manufactured by Baxter Healthcare Corp., Bioscience. 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 May 1, 2005. Regulation: 8.