EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN

EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN is an FDA 510(k)-cleared medical device (K853296) manufactured by Parexel Intl. 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 August 14, 1985. Regulation: 8.