FDA 510(k) Application Details - K141973

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K141973
Device Name Powered Laser Surgical Instrument
Applicant BEIJING ANCHORFREE TECHNOLOGY CO., LTD
P.O.BOX 237-023
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 GEX
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Date Received 07/21/2014
Decision Date 10/06/2014
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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