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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, auditory, evoked response
510(k) Number K012415
Device Name AURIS AEP
Applicant
SYNAPSYS, INC.
150-10 132 AVE.
JAMAICA,  NY  11434
Applicant Contact JULIEN CHAUSSY
Correspondent
SYNAPSYS, INC.
150-10 132 AVE.
JAMAICA,  NY  11434
Correspondent Contact JULIEN CHAUSSY
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received07/30/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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