The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Ureteral Dilators And Percutaneous Nephrostomy Dilators.
| Device ID | K170531 |
| 510k Number | K170531 |
| Device Name: | Ureteral Dilators And Percutaneous Nephrostomy Dilators |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Cori Ragan |
| Correspondent | Cori Ragan Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-22 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03600040300510 | K170531 | 000 |
| 03600040300480 | K170531 | 000 |
| 03600040256077 | K170531 | 000 |
| 03600040256022 | K170531 | 000 |
| 03600040255957 | K170531 | 000 |
| 03600040255889 | K170531 | 000 |
| 03600040255834 | K170531 | 000 |
| 03600040255780 | K170531 | 000 |
| 03600040255735 | K170531 | 000 |