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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name tympanic membrane direct contact hearing aid
De Novo Number DEN150002
Device Name EarLens Contact Hearing Device
Requester
earlens corporation
4045-a cambbell avenue
menlo park,  CA  94025
Contact suzanne levy
Regulation Number874.3315
Classification Product Code
PLK  
Date Received01/02/2015
Decision Date 09/29/2015
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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