MODIFICATION TO: PLEXALONG SETS

MODIFICATION TO: PLEXALONG SETS is an FDA 510(k)-cleared medical device (K042979) manufactured by Pajunk GmbH. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2004. Regulation: 8.