
Smith & Nephew Richards, Inc.
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HAPES MALLEABLE INCUS STAPES is an FDA 510(k)-cleared medical device (K950984) manufactured by Smith & Nephew Richards, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1995. Regulation: 8.

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