SURGICAL MASK (NON-STERILE)

SURGICAL MASK (NON-STERILE) is an FDA 510(k)-cleared medical device (K955513) manufactured by United Medical Ent., 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 21, 1996. Regulation: 8.