The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Endotracheal Tube Holder.
| Device ID | K802601 |
| 510k Number | K802601 |
| Device Name: | ENDOTRACHEAL TUBE HOLDER |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-21 |
| Decision Date | 1980-12-18 |