MODIFICATION TO PLEXOLONG SETS

MODIFICATION TO PLEXOLONG SETS is an FDA 510(k)-cleared medical device (K023218) 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 March 23, 2003. Regulation: 8.