The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Ureteral Balloon Dilation Catheter Set.
| Device ID | K040127 |
| 510k Number | K040127 |
| Device Name: | COOK URETERAL BALLOON DILATION CATHETER SET |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Debbie Schmitt |
| Correspondent | Debbie Schmitt COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-21 |
| Decision Date | 2004-04-06 |
| Summary: | summary |