Device Classification Name |
percutaneous nerve stimulator for opioid withdrawal
|
510(k) Number |
K201873 |
Device Name |
Sparrow Therapy System |
Applicant |
Spark Biomedical, Inc. |
18208 Preston Road, Suite D9-531 |
Dallas,
TX
75252
|
|
Applicant Contact |
Daniel Powell |
Correspondent |
AcKnowledge Regulatory Strategies, LLC |
2251 San Diego Avenue, Suite B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Michelle Rubin-Onur |
Regulation Number | 882.5896
|
Classification Product Code |
|
Date Received | 07/07/2020 |
Decision Date | 01/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04075214
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|