
American Surgical Mask Company, LLC
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ASM-301 Level 3 Surgical Mask is an FDA 510(k)-cleared medical device (K211440) manufactured by American Surgical Mask Company, 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 June 1, 2021. Regulation: 8.