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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 cutaneous electrode stimulator for urinary incontinence
De Novo Number DEN170049
Device Name Innovo
Requester
Bio-Medical Research Ltd.
parkmore business park west
galway,  IE h91nht7
Contact anne-marie keenan
Regulation Number876.5330
Classification Product Code
QAJ  
Date Received09/18/2017
Decision Date 11/06/2018
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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