FDA 510(k) Application Details - K123889

Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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510(K) Number K123889
Device Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant THERAVANT CORPORATION
131 Kelekent Lane
Cary, NC 27518 US
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Contact Marcy Moore
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Regulation Number 878.4810

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Classification Product Code ONF
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Date Received 12/18/2012
Decision Date 03/04/2013
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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