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Barrx Medical, Incorporated
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HALO 360 & SIZING BALLOON, MODEL 3441C is an FDA 510(k)-cleared medical device (K093855) 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 January 14, 2010. Regulation: 8.