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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 K153634
Device Name Wireless Earlens Light Driven Hearing Aid
Applicant
Earlens Corporation
4045-A Campbell Ave.
Menlo Park,  CA  94025
Applicant Contact Deborah Arthur
Correspondent
Earlens Corporation
4045-A Campbell Ave.
Menlo Park,  CA  94025
Correspondent Contact Deborah Arthur
Regulation Number874.3315
Classification Product Code
PLK  
Date Received12/18/2015
Decision Date 04/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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