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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
Predetermined Change
Control Plan Authorized		 No
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