The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Nutrisafe 2 Feeding Tube.
| Device ID | K121105 |
| 510k Number | K121105 |
| Device Name: | NUTRISAFE 2 FEEDING TUBE |
| Classification | Tube, Feeding |
| Applicant | VYGON CORP. 103A PARK ROAD Montgomeryville, PA 18936 |
| Contact | Jillian Mikovich |
| Correspondent | Jillian Mikovich VYGON CORP. 103A PARK ROAD Montgomeryville, PA 18936 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-12-18 |
| Summary: | summary |