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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 K080955
Device Name ZEN PROGRAM (MIND 440 HEARING AID)
Applicant
WIDEX HEARING AID CO., INC.
2300 CABOT DRIVE
SUITE 415
LISLE,  IL  60532
Applicant Contact FRANCIS KUK
Correspondent
WIDEX HEARING AID CO., INC.
2300 CABOT DRIVE
SUITE 415
LISLE,  IL  60532
Correspondent Contact FRANCIS KUK
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/03/2008
Decision Date 06/27/2008
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
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