The following data is part of a premarket notification filed by Vygon S A with the FDA for Boussignac/vygon Endotracheal Tube, Model 6501.25/30/35 And 6502.70/75/80.
| Device ID | K040657 |
| 510k Number | K040657 |
| Device Name: | BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | VYGON S A 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Contact | Laetitia Bernard |
| Correspondent | Laetitia Bernard VYGON S A 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-12 |
| Decision Date | 2004-06-10 |
| Summary: | summary |