OWEN MUMFORD 3ML AUTOPEN

OWEN MUMFORD 3ML AUTOPEN is an FDA 510(k)-cleared medical device (K983974) manufactured by Owen Mumford USA, Inc.. 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 20, 1998. Regulation: 8.