The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe-vario Tracheostomy Tubes (various) Reference Models: 450, 455, 460, 465, 470.
| Device ID | K051587 |
| 510k Number | K051587 |
| Device Name: | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | TRACOE MEDICAL GMBH 117 FLANDERS ROAD Westborough, MA 01581 |
| Contact | Michael A Warren |
| Correspondent | Michael A Warren TRACOE MEDICAL GMBH 117 FLANDERS ROAD Westborough, MA 01581 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-10-25 |