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Rusch Intl.
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RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K030559) 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 June 29, 2003. Regulation: 8.