
Berkley Medical Resources, Inc.
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2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD is an FDA 510(k)-cleared medical device (K962286) manufactured by Berkley Medical Resources, 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 6, 1996. Regulation: 8.