The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Percutaneous Renal Dilator Set.
| Device ID | K850355 |
| 510k Number | K850355 |
| Device Name: | MENTOR PERCUTANEOUS RENAL DILATOR SET |
| Classification | Dilator, Catheter, 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 | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-03-12 |