Pre-market Notification Details
| DeNovo ID | DEN170018 |
| Device Name: | NSS-2 System |
| Classification | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Applicant | Innovative Health Solutions (IHS), Inc. 829 South Adams St. Versailles, IN 47042 |
| Contact | Tom Carrico |
| Product Code | PZR |
| CFR Regulation Number | 882.5896 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2017-03-17 |
| Decision Date | 2017-11-15 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|
| B327NSS200 |
DEN170018 |
000 |
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