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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 K103760
Device Name TITAN
Applicant
INTERACOUSTICS A/S
DREJERVAENGET 8
ASSENS,  DK DK-5610
Applicant Contact ERIK NIELSEN
Correspondent
INTERACOUSTICS A/S
DREJERVAENGET 8
ASSENS,  DK DK-5610
Correspondent Contact ERIK NIELSEN
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received12/23/2010
Decision Date 05/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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