The following data is part of a premarket notification filed by Spr Therapeutics, Inc. with the FDA for Sprint Pns System.
Device ID | K202660 |
510k Number | K202660 |
Device Name: | SPRINT PNS System |
Classification | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
Applicant | SPR Therapeutics, Inc. 22901 Millcreek Blvd. Suite 110 Cleveland, OH 44122 |
Contact | Kathryn Stager |
Correspondent | Kathryn Stager SPR Therapeutics, Inc. 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 | 2020-09-14 |
Decision Date | 2021-01-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850022775093 | K202660 | 000 |
00850022775086 | K202660 | 000 |
00850022775079 | K202660 | 000 |
00850022775130 | K202660 | 000 |
00850022775123 | K202660 | 000 |
00850022775116 | K202660 | 000 |
00850022775109 | K202660 | 000 |
00854001007601 | K202660 | 000 |
00850022775321 | K202660 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPRINT PNS SYSTEM 98514555 not registered Live/Pending |
SPR Therapeutics, Inc. 2024-04-23 |