510(k) K191435
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 by
Nalu Medical, Inc.
— Product Code GZF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2019
- Date Received
- May 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5870
- Review Panel
- NE
- Submission Type