FDA 510(k) Application Details - K173006

Device Classification Name

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510(K) Number K173006
Device Name Cefaly Dual
Applicant CEFALY Technology
Rue Louis Plescia, 34
Seraing 4102 BE
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Contact Jean-Yves Mignolet
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Regulation Number

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Classification Product Code PCC
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Date Received 09/27/2017
Decision Date 11/28/2017
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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