
Adhezion Biomedical, LLC
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SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE is an FDA 510(k)-cleared medical device (K133963) 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 September 8, 2014. Regulation: 8.