OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS

OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS is an FDA 510(k)-cleared medical device (K060971) manufactured by Omi Manufacturing Pty., 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 23, 2006. Regulation: 8.