The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Ureteral Dilator Sets, Ureteral Dilators.
| Device ID | K173654 |
| 510k Number | K173654 |
| Device Name: | Ureteral Dilator Sets, Ureteral Dilators |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404 |
| Contact | Kotei Aoki |
| Correspondent | Kotei Aoki Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-28 |
| Decision Date | 2018-07-17 |
| Summary: | summary |