The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Nephrostomy Catheter.
| Device ID | K923097 |
| 510k Number | K923097 |
| Device Name: | URESIL NEPHROSTOMY CATHETER |
| Classification | Catheter, Nephrostomy |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Lev Melinyshyn |
| Correspondent | Lev Melinyshyn URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| 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 | 1992-06-25 |
| Decision Date | 1992-09-14 |