Dukal Corporation Level 1 Pediatric Face Mask

Dukal Corporation Level 1 Pediatric Face Mask is an FDA 510(k)-cleared medical device (K210321) manufactured by Dukal 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 March 28, 2022. Regulation: 8.