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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 K221168
Device Name Tinnitogram Signal Generator
Applicant
Goldenear Company, Inc.
24207 Via Perla
Santa Clarita,  CA  91354
Applicant Contact Daehee Lee
Correspondent
Goldenear Company, Inc.
24207 Via Perla
Santa Clarita,  CA  91354
Correspondent Contact Daehee Lee
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/22/2022
Decision Date 02/01/2023
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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