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Cryocath Technologies, Inc.
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SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE is an FDA 510(k)-cleared medical device (K053436) manufactured by Cryocath Technologies, 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 January 12, 2006. Regulation: 8.