FDA 510(k) Application Details - K183566

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K183566
Device Name Powered Laser Surgical Instrument
Applicant Lutronic Corporation
Lutronic Center, 219, Sowon-ro
Deogyang-gu, Goyang-si 410220 KR
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Contact James Childs
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 12/21/2018
Decision Date 06/14/2019
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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