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Omi Manufacturing Pty., Ltd.
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PERSONNA PLUS SAFETY SCALPEL SYSTEM is an FDA 510(k)-cleared medical device (K032242) manufactured by Omi Manufacturing Pty., Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 22, 2003. Regulation: 8.