The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracheotomy Tubes.
| Device ID | K781729 |
| 510k Number | K781729 |
| Device Name: | TRACHEOTOMY TUBES |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | TRACOE MEDICAL GMBH AM SCHLOSS, 20 D 6367 Karben 2, DE |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-10 |
| Decision Date | 1978-10-24 |