The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Guedel Airway 511 Vygon Bermann/orophar Airw.
| Device ID | K851480 |
| 510k Number | K851480 |
| Device Name: | VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW |
| Classification | High Pressure Liquid Chromatography, Codeine |
| 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 | LAE |
| CFR Regulation Number | 862.3270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-07 |