The following data is part of a premarket notification filed by Nalu Medical, Inc. with the FDA for Ipg, Integrated, 25/40 Cm, Single, Tined, Ipg, 2 Cm, Single 4, Lead (25/40 Cm, 4, Tined), Extension - 4.
| Device ID | K191435 |
| 510k Number | K191435 |
| Device Name: | IPG, Integrated, 25/40 Cm, Single, Tined, IPG, 2 Cm, Single 4, Lead (25/40 Cm, 4, Tined), Extension - 4 |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad, CA 92008 |
| Contact | Michele Chin-purcell |
| Correspondent | Michele Chin-purcell Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad, CA 92008 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-30 |
| Decision Date | 2019-09-06 |
| Summary: | summary |