The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Nutrisafe 2 Feeding Tubes Model 362.xxx. 1362.xxx.
| Device ID | K100163 |
| 510k Number | K100163 |
| Device Name: | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX |
| Classification | Tube, Feeding |
| Applicant | VYGON CORP. 103A PARK ROAD Montgomeryville, PA 18936 |
| Contact | Cindy Varughese |
| Correspondent | Cindy Varughese 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 | 2010-01-20 |
| Decision Date | 2011-10-13 |
| Summary: | summary |