The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Xro Gastro-duodenal, Dual Flow Tube, Salem Type.
| Device ID | K860285 |
| 510k Number | K860285 |
| Device Name: | XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| 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 | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-02-11 |