
Original Mattress Factory, Inc.
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3 Layer Surgical Mask (134252531) is an FDA 510(k)-cleared medical device (K231618) manufactured by Original Mattress Factory, 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 July 27, 2023. Regulation: 8.