All 510(k) submitters must include a statement certifying that all information in the application is truthful and accurate, and that no material fact has been omitted. The statement may be in the cover letter, or on a separate page. In either case, the location of this statement should be noted in the table of contents.
22.7.2.1 Device Name
The device name, including both the trade or proprietary name and the classification name, must be included.116