
Closure Medical Corp.
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OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 is an FDA 510(k)-cleared medical device (K980159) manufactured by Closure Medical Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 1998. Regulation: 8.