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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 K123450
Device Name PHONAK TINNITUS BALANCE
Applicant
PHONAK LLC
4520 WEAVER PARKWAY
WARRENVILLE,  IL  60555
Applicant Contact LAURA ELLMAN
Correspondent
PHONAK LLC
4520 WEAVER PARKWAY
WARRENVILLE,  IL  60555
Correspondent Contact LAURA ELLMAN
Regulation Number874.3400
Classification Product Code
KLW  
Date Received11/09/2012
Decision Date 02/11/2013
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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