The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for Bronchi And Gastrointestinal Cytology Brush.
| Device ID | K171607 |
| 510k Number | K171607 |
| Device Name: | Bronchi And Gastrointestinal Cytology Brush |
| Classification | Endoscopic Cytology Brush |
| Applicant | Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Doris A. Hawks |
| Correspondent | Doris A. Hawks Wilson-Cook Medical, Inc. / Cook Endoscopy 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 | 2017-06-01 |
| Decision Date | 2017-07-31 |
| Summary: | summary |