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Medtronic PS Medical
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BIPOLAR PENCIL, MODEL 3901-002, 3900-002 is an FDA 510(k)-cleared medical device (K010487) manufactured by Medtronic PS Medical. 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 2, 2001. Regulation: 8.