The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Nutrisafe Extension Tube.
| Device ID | K991918 |
| 510k Number | K991918 |
| Device Name: | NUTRISAFE EXTENSION TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff 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 | 1999-06-07 |
| Decision Date | 1999-10-29 |