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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 K221698
Device Name Eargo 5 , Eargo 6
Applicant
Eargo, Inc.
2665 N. First St., Suite 300
San Jose,  CA  95134
Applicant Contact Monica Barrett
Correspondent
Eargo, Inc.
2665 N. First St., Suite 300
San Jose,  CA  95134
Correspondent Contact Monica Barrett
Regulation Number874.3325
Classification Product Code
QUH  
Date Received06/13/2022
Decision Date 12/21/2022
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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