ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)

ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) is an FDA 510(k)-cleared medical device (K972849) manufactured by Cypress Medical Products, 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 May 27, 1998. Regulation: 8.