The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Williams Flexible Cystoscopic Injection Needle.
| Device ID | K865086 |
| 510k Number | K865086 |
| Device Name: | WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-30 |
| Decision Date | 1987-03-10 |