INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE

INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE is an FDA 510(k)-cleared medical device (K050131) 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 April 4, 2005. Regulation: 8.