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Barrx Medical, Incorporated
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HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A is an FDA 510(k)-cleared medical device (K092487) manufactured by Barrx Medical, Incorporated. 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 9, 2009. Regulation: 8.