BOUNDARY SINGLE-USE OR GOWN

BOUNDARY SINGLE-USE OR GOWN is an FDA 510(k)-cleared medical device (K842958) manufactured by Procter & Gamble Mfg. Co.. 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 August 16, 1984. Regulation: 8.