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Gyrus Acmi, Inc.
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PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK is an FDA 510(k)-cleared medical device (K080093) manufactured by Gyrus Acmi, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2008. Regulation: 8.