AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM is an FDA 510(k)-cleared medical device (K013242) manufactured by STERIS Corporation. 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 December 12, 2001. Regulation: 8.