Device Classification Name |
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
|
510(k) Number |
K170902 |
Device Name |
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit |
Applicant |
SPR Therapeutics, LLC |
22901 Millcreek Blvd., Suite 110 |
Cleveland,
OH
44122
|
|
Applicant Contact |
Kathryn Stager |
Correspondent |
SPR Therapeutics, LLC |
22901 Millcreek Blvd., Suite 110 |
Cleveland,
OH
44122
|
|
Correspondent Contact |
Kathryn Stager |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 03/28/2017 |
Decision Date | 06/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|