The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary Catheter, Uresil Nephro-ureteral S.
| Device ID | K972583 |
| 510k Number | K972583 |
| Device Name: | URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| 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 | FGE |
| Subsequent Product Code | GBO |
| Subsequent Product Code | GBX |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-08-29 |