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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tympanic membrane direct contact hearing aid
510(k) Number K182480
Device Name Earlens Contact Hearing Aid
Applicant
Earlens Corporation
4045 Campbell Avenue
Menlo Park,  CA  94025
Applicant Contact Judith A. Brimacombe
Correspondent
Earlens Corporation
4045 Campbell Avenue
Menlo Park,  CA  94025
Correspondent Contact Judith A. Brimacombe
Regulation Number874.3315
Classification Product Code
PLK  
Date Received09/10/2018
Decision Date 01/25/2019
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
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