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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 percutaneous nerve stimulator for opioid withdrawal
De Novo Number DEN170018
Device Name NSS-2 System
Requester
Innovative Health Solutions (IHS), Inc.
829 south adams st.
versailles,  IN  47042
Contact tom carrico
Regulation Number882.5896
Classification Product Code
PZR  
Date Received03/17/2017
Decision Date 11/15/2017
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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