The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Quantum Ttc Biliary Balloon Dilator.
| Device ID | K171223 |
| 510k Number | K171223 |
| Device Name: | Quantum TTC Biliary Balloon Dilator |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Tiffanny A. Thomas |
| Correspondent | Tiffanny A. Thomas Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-26 |
| Decision Date | 2017-06-16 |
| Summary: | summary |