The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil General Purpose Drainage Catheter.
| Device ID | K912109 |
| 510k Number | K912109 |
| Device Name: | URESIL GENERAL PURPOSE DRAINAGE CATHETER |
| Classification | Catheter, Nephrostomy, General & Plastic Surgery |
| 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 | GBO |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-08-12 |