Device Classification Name |
Percutaneous Nerve Stimulator For Opioid Withdrawal
|
510(k) Number |
K233166 |
Device Name |
NET Recovery Corp/NET Device |
Applicant |
Net Recovery |
155 N Riverview Dr, Suite 114 |
Anaheim Hills,
CA
92808
|
|
Applicant Contact |
Joe Winston |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J Smith |
Regulation Number | 882.5896
|
Classification Product Code |
|
Date Received | 09/27/2023 |
Decision Date | 05/29/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04916600
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|