SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET

SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET is an FDA 510(k)-cleared medical device (K964876) manufactured by Vlv Associates, 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 February 27, 1997. Regulation: 8.