
Safety-Med Products, Inc.
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PROTECTION PLUS EARLOOP PROCEDURE MASK is an FDA 510(k)-cleared medical device (K042654) manufactured by Safety-Med Products, 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 December 16, 2004. Regulation: 8.