
Biodermis Corp.
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CRYOSIL SILICONE GEL SHEETING is an FDA 510(k)-cleared medical device (K964047) manufactured by Biodermis Corp.. 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 March 18, 1997. Regulation: 8.