The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Tecothane 55d.
| Device ID | K950425 |
| 510k Number | K950425 |
| Device Name: | TECOTHANE 55D |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Contact | David H Mueller |
| Correspondent | David H Mueller MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-02 |
| Decision Date | 1995-04-19 |