
Coloplast Corp.
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NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 is an FDA 510(k)-cleared medical device (K122968) manufactured by Coloplast Corp.. 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 December 17, 2012. Regulation: 8.