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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, transcutaneous system
De Novo Number DEN020003
510(K) Number K013298
Device Name RETROX
Requester
auric hearing systems, inc.
8 fenno way
nahant,  MA  01908
Contact david j navaroli
Regulation Number874.3950
Classification Product Code
NIX  
Date Received06/21/2002
Decision Date 08/20/2002
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
Type Post-NSE
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