The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Multi-dose Vial Adapter & Bionector.
| Device ID | K963571 |
| 510k Number | K963571 |
| Device Name: | VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-05 |
| Decision Date | 1997-06-02 |