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Geister Medizin Technik GmbH
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VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 is an FDA 510(k)-cleared medical device (K022823) manufactured by Geister Medizin Technik GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 30, 2004. Regulation: 8.