The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Salle Intraoperative Pyeloplasty Stent Set.
| Device ID | K170010 |
| 510k Number | K170010 |
| Device Name: | Salle Intraoperative Pyeloplasty Stent Set |
| Classification | Stent, Ureteral |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Minjin Choi |
| Correspondent | Minjin Choi COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-08-28 |