The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vance Urethal Dilator Set.
| Device ID | K810371 |
| 510k Number | K810371 |
| Device Name: | VANCE URETHAL DILATOR SET |
| Classification | Dilator, Urethral |
| Applicant | VANCE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-12 |
| Decision Date | 1981-03-20 |