
American Convertors Div., American Pharmaseal
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TACKMER INCISE DRAPE is an FDA 510(k)-cleared medical device (K802050) manufactured by American Convertors Div., American Pharmaseal. 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 September 15, 1980. Regulation: 8.