The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Entuit Nasal Jejunal Feeding Tube.
Device ID | K201322 |
510k Number | K201322 |
Device Name: | Entuit Nasal Jejunal Feeding Tube |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
Contact | Tiffanny A Thomas |
Correspondent | Tiffanny A Thomas Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-18 |
Decision Date | 2020-06-17 |