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Barrx Medical, Incorporated
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BARRX HALO 360 SYSTEM, MODEL 1100C-115A is an FDA 510(k)-cleared medical device (K051168) 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 June 28, 2005. Regulation: 8.