Savvy Surgical Mask - Level 3

Savvy Surgical Mask - Level 3 is an FDA 510(k)-cleared medical device (K230383) manufactured by Alg Health, LLC. 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 5, 2023. Regulation: 8.