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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 K211008
Device Name Bose SoundControl Hearing Aids
Bose Corporation
The Mountain Rd.
Framingham,  MA  01701
Applicant Contact Bryn Kieras
Bose Corporation
The Mountain Rd.
Framingham,  MA  01701
Correspondent Contact Bryn Kieras
Regulation Number874.3325
Classification Product Code
Subsequent Product Code
Date Received04/05/2021
Decision Date 05/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No