The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Exchange Transfusion Tray 275.00.
| Device ID | K851477 |
| 510k Number | K851477 |
| Device Name: | VYGON EXCHANGE TRANSFUSION TRAY 275.00 |
| Classification | Set, Blood Transfusion |
| Applicant | VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Tony J Rivers |
| Correspondent | Tony J Rivers VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-03 |