The following data is part of a premarket notification filed by Dornier Medtech America Inc. with the FDA for Dornier Ureteral Stent.
| Device ID | K190312 |
| 510k Number | K190312 |
| Device Name: | Dornier Ureteral Stent |
| Classification | Stent, Ureteral |
| Applicant | Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2019-11-15 |