The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Unistent Ureteral Stent Set.
| Device ID | K875038 |
| 510k Number | K875038 |
| Device Name: | MENTOR UNISTENT URETERAL STENT SET |
| Classification | Stent, Ureteral |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | R Breckenridge |
| Correspondent | R Breckenridge 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 | 1987-12-07 |
| Decision Date | 1988-03-03 |