The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Ureteral Dilator.
| Device ID | K840746 |
| 510k Number | K840746 |
| Device Name: | URETERAL DILATOR |
| Classification | Dilator, Urethral |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-19 |
| Decision Date | 1984-04-13 |