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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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