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Gyrus Ent LLC
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DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE is an FDA 510(k)-cleared medical device (K030343) manufactured by Gyrus Ent LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2003. Regulation: 8.