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Highland / Marietta, Inc.
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ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 is an FDA 510(k)-cleared medical device (K003403) manufactured by Highland / Marietta, 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 May 6, 2001. Regulation: 8.