FAR-EAST BARRIER GOWNS

FAR-EAST BARRIER GOWNS is an FDA 510(k)-cleared medical device (K971702) manufactured by Far East Science & Technology Development 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 July 7, 1997. Regulation: 8.