BOUNDARY SPECIALTY GOWN

BOUNDARY SPECIALTY GOWN is an FDA 510(k)-cleared medical device (K791062) 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 June 19, 1979. Regulation: 8.