The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Ureteral Dilation Set.
| Device ID | K832808 |
| 510k Number | K832808 |
| Device Name: | URETERAL DILATION SET |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | VAN-TEC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1983-10-14 |