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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, Prescription
510(k) Number K212609
Device Name BHA100 Series Braun Clear Hearing Aid
Applicant
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough,  MA  01752
Applicant Contact Matt J. Baun
Correspondent
Kaz USA, Inc., A Helen of Troy Company
400 Donald Lynch Blvd., Suite 300
Marlborough,  MA  01752
Correspondent Contact Matt J. Baun
Regulation Number874.3325
Classification Product Code
QDD  
Date Received08/17/2021
Decision Date 01/05/2022
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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