BI-3M NEEDLE-FREE INJECTOR SYSTEM

BI-3M NEEDLE-FREE INJECTOR SYSTEM is an FDA 510(k)-cleared medical device (K013256) manufactured by Felton International, 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 6, 2001. Regulation: 8.