The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for Gastrointestinal Injection Needles (vin, Ldvi, Dvi And Mhi).
| Device ID | K190829 |
| 510k Number | K190829 |
| Device Name: | Gastrointestinal Injection Needles (VIN, LDVI, DVI And MHI) |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Tiffanny A Thomas |
| Correspondent | Tiffanny A Thomas Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-12-19 |