FDA 510(k) Application Details - K003403

Device Classification Name Electrode, Electrosurgical

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510(K) Number K003403
Device Name Electrode, Electrosurgical
Applicant HIGHLAND / MARIETTA, INC.
6155 HEISLEY RD.
MENTOR, OH 44060 US
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Contact JOHN NIKSA
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Regulation Number 878.4400

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Classification Product Code JOS
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Date Received 11/01/2000
Decision Date 05/07/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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