SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE is an FDA 510(k)-cleared medical device (K042936) manufactured by Baxter Healthcare 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 November 25, 2004. Regulation: 8.