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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(k) Number K223137
Device Name Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
Applicant
Hearx SA (Pty) , Ltd.
Bldg. 2, Ashlea Gardens Office Park, 180 Garsfontein Rd.
Ashlea Gardens
Pretoria,  ZA 0081
Applicant Contact Seline Van Der Wat
Correspondent
Hearx SA (Pty) , Ltd.
Bldg. 2, Ashlea Gardens Office Park, 180 Garsfontein Rd.
Ashlea Gardens
Pretoria,  ZA 0081
Correspondent Contact Seline Van Der Wat
Regulation Number874.3325
Classification Product Code
QUH  
Date Received10/04/2022
Decision Date 03/14/2023
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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