The following data is part of a premarket notification filed by Uresil, Llc with the FDA for Uresil Gastrostomy Catheter Kit , Model Gcl-630hbk.
| Device ID | K093653 |
| 510k Number | K093653 |
| Device Name: | URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | URESIL, LLC 5418 WEST TOUHY AVE. Skokie, IL 60077 |
| Contact | Lev Melinyshyn |
| Correspondent | Lev Melinyshyn URESIL, LLC 5418 WEST TOUHY AVE. Skokie, IL 60077 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2010-02-23 |