The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Neo-sump.
| Device ID | K974806 |
| 510k Number | K974806 |
| Device Name: | VYGON NEO-SUMP |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne Marie Cesario |
| Correspondent | Anne Marie Cesario VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-03-23 |