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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 hearing aid, air-conduction with wireless technology, prescription
De Novo Number DEN100025
510(K) Number K101699
Device Name WIDEXLINK IN CLEAR SERIES HEARING AIDS
Requester
OFFICE RESEARCH IN CLINICAL AMPLIFICTION
2300 cabot drive
suite 415
lisle,  IL  60532
Contact francis kuk
Regulation Number874.3305
Classification Product Code
OSM  
Date Received10/13/2010
Decision Date 03/31/2011
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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