The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Bionector With Extension Set.
| Device ID | K963981 |
| 510k Number | K963981 |
| Device Name: | VYGON BIONECTOR WITH EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne Marie Cesario |
| Correspondent | Anne Marie Cesario VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-03 |
| Decision Date | 1997-02-14 |