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Alpha Protech, Inc.
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N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 is an FDA 510(k)-cleared medical device (K092824) manufactured by Alpha Protech, 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 October 20, 2009. Regulation: 8.