3rd party straw man to keep shareholder's off Tom's back while he dilutes the company into oblivion.
What kind of a real company can't get their own product approved by the FDA after six years and then needs to bring in someone else to do the job. What is this company supposed to do? Re-design the product?
That is a confirmation the 510k was submitted. ETC is making sure the submission is accepted and approved. They will take over managing the process. Stop the false narrative.