The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Ductal Catheters.
| Device ID | K895285 |
| 510k Number | K895285 |
| Device Name: | MENTOR DUCTAL CATHETERS |
| Classification | Catheter, Cholangiography |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Byron Wickett |
| Correspondent | Byron Wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-24 |
| Decision Date | 1989-10-17 |