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Optivia Medical, LLC
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OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL is an FDA 510(k)-cleared medical device (K053583) manufactured by Optivia Medical, LLC. 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 March 30, 2006. Regulation: 8.

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