The following data is part of a premarket notification filed by Uresil, Llc with the FDA for Modification To: Gp General Purpose Drainage Catheter, Mini-pig Drainage Catheter, Nephrostomy Catheter, Biliary.
| Device ID | K041995 |
| 510k Number | K041995 |
| Device Name: | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY |
| Classification | Catheter, Nephrostomy, General & Plastic Surgery |
| Applicant | URESIL, LLC 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Matthew Mahon |
| Correspondent | Matthew Mahon URESIL, LLC 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | GBO |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2004-08-19 |