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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name masker, tinnitus
510(k) Number K171243
Device Name audifon Tinnitus-Module
Applicant
audiofon USA Inc.
403 Chairman CT., Suite 1
Debary,  FL  32713
Applicant Contact Jane E. Perrone
Correspondent
audiofon USA Inc.
403 Chairman CT., Suite 1
Debary,  FL  32713
Correspondent Contact Jane E. Perrone
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/28/2017
Decision Date 10/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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