WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD

WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD is an FDA 510(k)-cleared medical device (K023755) manufactured by Winner Industries (Shenzhen) 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 June 9, 2003. Regulation: 8.