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FDA 510(k) Application Details - K012415
Device Classification Name
Stimulator, Auditory, Evoked Response
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510(K) Number
K012415
Device Name
Stimulator, Auditory, Evoked Response
Applicant
SYNAPSYS, INC.
150-10 132 AVE.
JAMAICA, NY 11434 US
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Contact
JULIEN CHAUSSY
Other 510(k) Applications for this Contact
Regulation Number
882.1900
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Classification Product Code
GWJ
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More FDA Info for this Product Code
Date Received
07/30/2001
Decision Date
12/18/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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