I.V. EXTENSION SET OR I.V. ADMINISTRATION SET

I.V. EXTENSION SET OR I.V. ADMINISTRATION SET is an FDA 510(k)-cleared medical device (K983073) manufactured by Integra Biotechnical, LLC. 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 15, 1998. Regulation: 8.