The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon - Enteral Feeding Tube - Polyurethane.
| Device ID | K925854 |
| 510k Number | K925854 |
| Device Name: | VYGON - ENTERAL FEEDING TUBE - POLYURETHANE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-17 |
| Decision Date | 1994-05-02 |