
Changzhou City Zhiye Medical Devices Institute Co.
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DISPOSABLE CIRCULAR STAPLER is an FDA 510(k)-cleared medical device (K131303) manufactured by Changzhou City Zhiye Medical Devices Institute Co.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2013. Regulation: 8.