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Coloplast A/S
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VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT is an FDA 510(k)-cleared medical device (K113496) 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 February 13, 2012. Regulation: 8.