SURGICAL GOWN (EO STERILIZED)

SURGICAL GOWN (EO STERILIZED) is an FDA 510(k)-cleared medical device (K112796) manufactured by Cobes Industries Co., Ltd.. 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 September 11, 2013. Regulation: 8.