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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 K121847
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 Number874.1090
Classification Product Code
ETY  
Subsequent Product Code
GWJ  
Date Received06/25/2012
Decision Date 11/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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