The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Laparoscopic Cholangiography Catheter.
| Device ID | K915343 |
| 510k Number | K915343 |
| Device Name: | URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| 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 | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-03-31 |