FDA 510(k) Application Details - DEN120019

Device Classification Name

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510(K) Number DEN120019
Device Name CEFALY
Applicant STX-MED SPRL
ZI DES HAUNTS SARTS
4E AVENUE 5
HERSTAL, LIEGE 4040 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 12/13/2012
Decision Date 03/11/2014
Decision DENG -
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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