MEDISYSTEMS LUER ACCESS INJECTION SITE

MEDISYSTEMS LUER ACCESS INJECTION SITE is an FDA 510(k)-cleared medical device (K010279) manufactured by Medisystems Corp.. 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 May 28, 2001. Regulation: 8.