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Blue Sky Medical Group Incorporated
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VERSATILE 1 EZCARE WOUND VACUUM SYSTEM is an FDA 510(k)-cleared medical device (K061919) manufactured by Blue Sky Medical Group 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 February 4, 2007. Regulation: 8.