PRESTIGE AMERITECH FACE MASK

PRESTIGE AMERITECH FACE MASK is an FDA 510(k)-cleared medical device (K061716) manufactured by Prestige Ameritech. 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 13, 2006. Regulation: 8.