The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Multi-lead Trialing Cable Model 355531.
| Device ID | K102523 |
| 510k Number | K102523 |
| Device Name: | MULTI-LEAD TRIALING CABLE MODEL 355531 |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDTRONIC INC. 7000 CENTRAL AVENUE NE Minneapolis, MN 55432 -3576 |
| Contact | Trishia Dwyer |
| Correspondent | Trishia Dwyer MEDTRONIC INC. 7000 CENTRAL AVENUE NE Minneapolis, MN 55432 -3576 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2010-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169015371 | K102523 | 000 |
| 00643169986497 | K102523 | 000 |