AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE

AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE is an FDA 510(k)-cleared medical device (K121637) manufactured by Sunwell Biotech 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 October 24, 2012. Regulation: 8.