The following data is part of a premarket notification filed by Bentec Medical, Inc. with the FDA for Van Andle Dilation, Emerald Guidewire, Model Vad6, 502-726.
| Device ID | K002650 |
| 510k Number | K002650 |
| Device Name: | VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BENTEC MEDICAL, INC. 1380 EAST BEAMER ST. Woodland, CA 95776 |
| Contact | David Tucker |
| Correspondent | David Tucker BENTEC MEDICAL, INC. 1380 EAST BEAMER ST. Woodland, CA 95776 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-25 |
| Decision Date | 2001-02-16 |