The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Disposable Tracheal Tube.
| Device ID | K800634 |
| 510k Number | K800634 |
| Device Name: | OHIO DISPOSABLE TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | OHIO MEDICAL PRODUCTS 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 | 1980-03-21 |
| Decision Date | 1980-04-02 |