The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Spinal Anesthesia Tray Code No. 190.
| Device ID | K851474 |
| 510k Number | K851474 |
| Device Name: | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 |
| Classification | N-acetylprocainamide Control Materials |
| 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 | LAZ |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-07 |