
Adhezion Biomedical, LLC
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SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive is an FDA 510(k)-cleared medical device (K161011) manufactured by Adhezion Biomedical, 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 November 7, 2016. Regulation: 8.