DUOPRO SAFETY SYRINGE (DUOPROSS)

DUOPRO SAFETY SYRINGE (DUOPROSS) is an FDA 510(k)-cleared medical device (K020623) manufactured by M.K. Meditech Co. , Ltd.. 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 May 1, 2002. Regulation: 8.