The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Percutaneous Malecot Nephrostomy Set.
| Device ID | K850287 |
| 510k Number | K850287 |
| Device Name: | MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET |
| Classification | Catheter, Nephrostomy |
| 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 | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-24 |
| Decision Date | 1985-03-07 |