
Gri-Alleset, Inc.
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Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is an FDA 510(k)-cleared medical device (K210860) manufactured by Gri-Alleset, Inc.. 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 April 6, 2022. Regulation: 8.