Device Classification Name |
Percutaneous Nerve Stimulator For Opioid Withdrawal
|
510(k) Number |
K230796 |
Device Name |
Sparrow Ascent |
Applicant |
Spark Biomedical, Inc. |
18208 Preston Road, Suite D9-531 |
Dallas,
TX
75252
|
|
Applicant Contact |
Brent Croft |
Correspondent |
RQM+ |
2251 San Diego Avenue, Suite B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Allison Komiyama |
Regulation Number | 882.5896
|
Classification Product Code |
|
Date Received | 03/22/2023 |
Decision Date | 06/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|