FDA 510(k) Application Details - K131859

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

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510(K) Number K131859
Device Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant BEIJING HONKON TECHNOLOGIES CO., LTD
P.O. BOX 120-119
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 878.4810

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Classification Product Code ONF
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Date Received 06/24/2013
Decision Date 10/18/2013
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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