
Medal Intl. Sales Co., LLC
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VOLMED OPERATION DRAPE is an FDA 510(k)-cleared medical device (K955872) manufactured by Medal Intl. Sales Co., LLC. 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 March 11, 1996. Regulation: 8.