The following data is part of a premarket notification filed by Nalu Medical, Inc. with the FDA for Nalu Lead Blank (50cm).
| Device ID | K190960 |
| 510k Number | K190960 |
| Device Name: | Nalu Lead Blank (50cm) |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad, CA 92008 |
| Contact | Sunny Gill |
| Correspondent | Sunny Gill Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad, CA 92008 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-12 |
| Decision Date | 2019-07-11 |