The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilosn-cook Biliary Dilation Balloon.
| Device ID | K040800 |
| 510k Number | K040800 |
| Device Name: | WILOSN-COOK BILIARY DILATION BALLOON |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. 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 | 2004-03-29 |
| Decision Date | 2004-06-25 |
| Summary: | summary |