The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vnace Fascial Dilator Set.
| Device ID | K811833 |
| 510k Number | K811833 |
| Device Name: | VNACE FASCIAL DILATOR SET |
| Classification | Dilator, Urethral |
| Applicant | VANCE PRODUCTS, INC. MD |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-30 |
| Decision Date | 1981-07-10 |