The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Double Lumen Endotracheal Tube.
| Device ID | K960795 |
| 510k Number | K960795 |
| Device Name: | VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| 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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-27 |
| Decision Date | 1996-05-22 |