MODIFICATION TO: T-PORT HP INFUSION PORT

MODIFICATION TO: T-PORT HP INFUSION PORT is an FDA 510(k)-cleared medical device (K073210) manufactured by Pfm Medical, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 2007. Regulation: 8.