The following data is part of a premarket notification filed by Vygon with the FDA for Nutrisafe 2- Enfit Adaptor.
| Device ID | K151237 |
| 510k Number | K151237 |
| Device Name: | Nutrisafe 2- ENFit Adaptor |
| Classification | Enteral Specific Transition Connectors |
| Applicant | VYGON 2750 MORRIS ROAD, SUITE A200 Lansdale, PA 19446 |
| Contact | Jillian Mikovich |
| Correspondent | Jillian Mikovich VYGON 2750 MORRIS ROAD, SUITE A200 Lansdale, PA 19446 |
| Product Code | PIO |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-11 |
| Decision Date | 2016-02-09 |
| Summary: | summary |