The following data is part of a premarket notification filed by Spr Therapeutics, Llc with the FDA for 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.
| Device ID | K170902 |
| 510k 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 |
| Classification | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Applicant | SPR Therapeutics, LLC 22901 Millcreek Blvd., Suite 110 Cleveland, OH 44122 |
| Contact | Kathryn Stager |
| Correspondent | Kathryn Stager SPR Therapeutics, LLC 22901 Millcreek Blvd., Suite 110 Cleveland, OH 44122 |
| Product Code | NHI |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-28 |
| Decision Date | 2017-06-26 |
| Summary: | summary |