
Surgikos, Inc.
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BARRIER ANTIMICROBIAL INCISE DRAPE is an FDA 510(k)-cleared medical device (K820543) manufactured by Surgikos, Inc.. 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 July 21, 1982. Regulation: 8.