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Lac Mac, Ltd.
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LAC-MAC LIMITED INNERBLOC O.R. GOWN is an FDA 510(k)-cleared medical device (K030536) manufactured by Lac Mac, Ltd.. 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 May 5, 2003. Regulation: 8.