The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Nephro-ureteral Stent.
| Device ID | K942688 |
| 510k Number | K942688 |
| Device Name: | NEPHRO-URETERAL STENT |
| Classification | Catheter, Nephrostomy |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Matthew Curtis |
| Correspondent | Matthew Curtis 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 | 1994-06-07 |
| Decision Date | 1995-06-06 |