
Komet Medical, Div. of Brasseler USA I, L.P.
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KOMET SURGICAL BUR is an FDA 510(k)-cleared medical device (K883255) manufactured by Komet Medical, Div. of Brasseler USA I, L.P.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 14, 1988. Regulation: 8.