The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Double Lumen Biliary Cytology Brush.
| Device ID | K040324 |
| 510k Number | K040324 |
| Device Name: | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-10 |
| Decision Date | 2004-05-20 |
| Summary: | summary |