The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Model 3875 1 X 8 Sc Test Stimulation Lead.
| Device ID | K062041 |
| 510k Number | K062041 |
| Device Name: | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDTRONIC INC. 710 MEDTRONIC PARKWAY MAIL STOP LN145 Minneapolis, MN 55432 |
| Contact | Paula Cordero |
| Correspondent | Paula Cordero MEDTRONIC INC. 710 MEDTRONIC PARKWAY MAIL STOP LN145 Minneapolis, MN 55432 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994756602 | K062041 | 000 |
| 00613994756596 | K062041 | 000 |
| 00613994756589 | K062041 | 000 |
| 00613994722072 | K062041 | 000 |
| 00613994722065 | K062041 | 000 |
| 00613994189745 | K062041 | 000 |
| 00643169157774 | K062041 | 000 |
| 00643169157439 | K062041 | 000 |
| 00643169157422 | K062041 | 000 |