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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 K223694
Device Name Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
Applicant
Duearity AB
Krusegrand 42d
Malmo,  SE 21225
Applicant Contact Anneli Johansson
Correspondent
Duearity AB
Krusegrand 42d
Malmo,  SE 21225
Correspondent Contact Anneli Johansson
Regulation Number874.3400
Classification Product Code
KLW  
Date Received12/09/2022
Decision Date 06/30/2023
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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