TRILAMINATE DRAPES/TIBURON

TRILAMINATE DRAPES/TIBURON is an FDA 510(k)-cleared medical device (K023419) manufactured by Allegiance Healthcare Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2003. Regulation: 8.