FDA 510(k) Application Details - K170708

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K170708
Device Name Probe, Radiofrequency Lesion
Applicant Diros Technology Inc.
120 Gibson Drive
Markham L3R 2Z3 CA
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Contact Ron Baker
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 03/08/2017
Decision Date 06/27/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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