Device Classification Name |
Stimulator, Spinal-Cord, Implanted (Pain Relief)
|
510(k) Number |
K191466 |
Device Name |
SandShark Injectable Anchor (SIA) System |
Applicant |
Stimwave Technologies Inc. |
1310 Park Central Boulevard South |
Pompano Beach,
FL
33064
|
|
Applicant Contact |
Elizabeth Greene |
Correspondent |
Stimwave Technologies Inc. |
1310 Park Central Boulevard South |
Pompano Beach,
FL
33064
|
|
Correspondent Contact |
Elizabeth Greene |
Regulation Number | 882.5880
|
Classification Product Code |
|
Date Received | 06/03/2019 |
Decision Date | 11/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|