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510(k) DEN170018

NSS-2 System by Innovative Health Solutions (Ihs), Inc. — Product Code PZR

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: November 15, 2017
Date Received: March 17, 2017
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class: Class II
Regulation Number: 882.5896
Review Panel: NE
Submission Type

Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.