PROTEC-TOP, STERIDENT, BENTO

PROTEC-TOP, STERIDENT, BENTO is an FDA 510(k)-cleared medical device (K031022) manufactured by Ronpak, Inc.. 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 April 13, 2003. Regulation: 8.