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Gyrus Acmi, Inc.
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GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 is an FDA 510(k)-cleared medical device (K092278) manufactured by Gyrus Acmi, 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 September 28, 2009. Regulation: 8.

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