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 Number | 882.5896
|
Classification Product Code |
|
Date Received | 03/17/2017 |
Decision Date | 11/15/2017 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|