The following data is part of a premarket notification filed by Vitaltec Corporation with the FDA for Rota-trach Tracheostomy Tube Model Rota-trach.
| Device ID | K100480 |
| 510k Number | K100480 |
| Device Name: | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | VITALTEC CORPORATION NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min VITALTEC CORPORATION NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-18 |
| Decision Date | 2010-06-11 |
| Summary: | summary |