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 |