Mepiseal Soft Silicone Sealant

Mepiseal Soft Silicone Sealant is an FDA 510(k)-cleared medical device (K152741) manufactured by Molnlycke Health Care Us, 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 January 21, 2016. Regulation: 8.