Device Classification Name |
Percutaneous Nerve Stimulator For Opioid Withdrawal
|
510(k) Number |
K173861 |
Device Name |
Drug Relief |
Applicant |
DyAnsys, Inc. |
300 North Bayshore Boulevard |
San Mateo,
CA
94401
|
|
Applicant Contact |
San Mateo |
Correspondent |
DyAnsys, Inc. |
300 North Bayshore Boulevard |
San Mateo,
CA
94401
|
|
Correspondent Contact |
San Mateo |
Regulation Number | 882.5896
|
Classification Product Code |
|
Date Received | 12/20/2017 |
Decision Date | 05/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|