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Coloplast A/S
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VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT is an FDA 510(k)-cleared medical device (K111881) manufactured by Coloplast A/S. 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 16, 2011. Regulation: 8.