The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Fusion Cytology Brush, Cytomax Ii Double Lumen Cytology Brushes.
| Device ID | K192908 |
| 510k Number | K192908 |
| Device Name: | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes |
| Classification | Endoscopic Cytology Brush |
| 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 | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2019-11-14 |