FDA 510(k) Application Details - K191293

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K191293
Device Name Probe, Radiofrequency Lesion
Applicant LCCS Products Limited
Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai
Ying Pun
Hong Kong CN
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Contact Nick XU
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 05/14/2019
Decision Date 01/24/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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