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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K151616
Device Name AT235
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 Number874.1090
Classification Product Code
ETY  
Date Received06/15/2015
Decision Date 07/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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