
Premier North America, Inc.
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ENEO TOTALE (Model: ENEOT947) is an FDA 510(k)-cleared medical device (K213841) manufactured by Premier North America, 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 January 5, 2022. Regulation: 8.