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Gyrus Acmi, Inc.
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PK SUPERPULSE SYSEM GENERATOR MODEL 744000 is an FDA 510(k)-cleared medical device (K100816) 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 June 30, 2010. Regulation: 8.