RUSCH POLYFLEX STENT KIT

RUSCH POLYFLEX STENT KIT is an FDA 510(k)-cleared medical device (K013266) manufactured by Rusch Intl.. 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 November 26, 2001. Regulation: 8.