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Blue Sky Medical Group Incorporated
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BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 is an FDA 510(k)-cleared medical device (K061367) 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 August 9, 2006. Regulation: 8.