The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Dbl-coil Indwelling Polyurethane Ureteral-.
| Device ID | K850176 |
| 510k Number | K850176 |
| Device Name: | MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL- |
| Classification | Stent, Ureteral |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Gregory L Johnson |
| Correspondent | Gregory L Johnson MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-17 |
| Decision Date | 1985-02-28 |