The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Urethral Dilatation System.
| Device ID | K870695 |
| 510k Number | K870695 |
| Device Name: | VAN-TEC URETHRAL DILATATION SYSTEM |
| Classification | Dilator, Urethral |
| Applicant | VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
| Contact | James F Vance |
| Correspondent | James F Vance VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-19 |
| Decision Date | 1987-03-10 |