The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Hemospray Endoscopic Hemostat.
| Device ID | K200972 |
| 510k Number | K200972 |
| 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 |
| Correspondent | Marge Walls-walker Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | QAU |
| CFR Regulation Number | 878.4456 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-13 |
| Decision Date | 2020-06-10 |