| DeNovo ID | DEN170015 |
| Device Name: | Hemospray Endoscopic Hemostat |
| Classification | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Product Code | QAU |
| CFR Regulation Number | 878.4456 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2017-03-09 |
| Decision Date | 2018-05-07 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |