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 Brush.
| Device ID | K181317 |
| 510k Number | K181317 |
| Device Name: | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush |
| Classification | Endoscopic Cytology Brush |
| Applicant | Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Sierra Lowe |
| Correspondent | Sierra Lowe 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-18 |
| Decision Date | 2019-02-08 |
| Summary: | summary |