FDA 510(k) Application Details - K152642

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K152642
Device Name Probe, Radiofrequency Lesion
Applicant LCCS PRODUCTS LIMITED
FLAT A, 9/F ., HENNESSY PLAZA, 164-166 HENNESSY ROAD,
WANCHAI
HONG KONG CN
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Contact JAMES LIN
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 09/15/2015
Decision Date 08/26/2016
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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