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FDA 510(k) Application Details - K101534

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K101534
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant CONMED CORP.
14603 E. FREMONT AVE.
CENTENNIAL, CO US
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Contact SHAWN REIDEL
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/03/2010
Decision Date 11/24/2010
Decision SE - Substantially Equivalent
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 Y
Expedited Review N



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