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Genadyne Biotechnologies, Inc.
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LUCINA-MELODI is an FDA 510(k)-cleared medical device (K112856) manufactured by Genadyne Biotechnologies, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 2012. Regulation: 8.

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