MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL is an FDA 510(k)-cleared medical device (K083765) manufactured by Medegen Medical Manufacturing Services. 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 29, 2008. Regulation: 8.