
Poly-Medics,Inc.
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HARD TISSUE REPLACEMENT (HTR) GRANULAR is an FDA 510(k)-cleared medical device (K934861) manufactured by Poly-Medics,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 November 3, 1994. Regulation: 8.