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Lac Mac, Ltd.
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INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) is an FDA 510(k)-cleared medical device (K032631) 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 February 4, 2004. Regulation: 8.