The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Models 3987 And 3988 Resume Lead For Pns.
| Device ID | K920567 |
| 510k Number | K920567 |
| Device Name: | MODELS 3987 AND 3988 RESUME LEAD FOR PNS |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Daryle Petersen |
| Correspondent | Daryle Petersen MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-07 |
| Decision Date | 1992-05-20 |