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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035324031856 | K781729 | 000 |
| 04035324032266 | K781729 | 000 |
| 04035324032280 | K781729 | 000 |
| 04035324032242 | K781729 | 000 |
| 04035324032273 | K781729 | 000 |
| 04035324032259 | K781729 | 000 |
| 04035324032235 | K781729 | 000 |
| 04035324032198 | K781729 | 000 |
| 04035324032204 | K781729 | 000 |
| 04035324032303 | K781729 | 000 |