The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Vygon Endotracheal Tubes.
| Device ID | K813373 |
| 510k Number | K813373 |
| Device Name: | VYGON ENDOTRACHEAL TUBES |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | EXCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-01 |
| Decision Date | 1981-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 53660812005567 | K813373 | 000 |
| 33660812005556 | K813373 | 000 |