Prestige Ameritech Pediatric/Child’s Face mask

Prestige Ameritech Pediatric/Child’s Face mask is an FDA 510(k)-cleared medical device (K160100) 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 October 6, 2016. Regulation: 8.