The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Biliary Balloon Catheter.
| Device ID | K863571 |
| 510k Number | K863571 |
| Device Name: | BILIARY BALLOON CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Michael Jaron |
| Correspondent | Michael Jaron URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-12 |
| Decision Date | 1986-11-04 |