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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 K180495
Device Name Tinnitus Sound Generator Module
Applicant
GN Hearing A/S
Lautrupbjerg 7
Ballerup,  DK 2750
Applicant Contact Lars Hagander
Correspondent
GN Hearing A/S
Lautrupbjerg 7
Ballerup,  DK 2750
Correspondent Contact Lars Hagander
Regulation Number874.3400
Classification Product Code
KLW  
Date Received02/26/2018
Decision Date 11/30/2018
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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