The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Zilver Biliary Stent.
| Device ID | K020788 |
| 510k Number | K020788 |
| Device Name: | WILSON-COOK ZILVER BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Margaret J Posner |
| Correspondent | Margaret J Posner WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-11 |
| Decision Date | 2002-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002257310 | K020788 | 000 |
| 10827002257303 | K020788 | 000 |
| 10827002257297 | K020788 | 000 |
| 10827002257280 | K020788 | 000 |
| 10827002257273 | K020788 | 000 |
| 10827002257266 | K020788 | 000 |
| 10827002257259 | K020788 | 000 |
| 10827002257242 | K020788 | 000 |
| 10827002257235 | K020788 | 000 |