Arch Therapeutics Inc (ARTH)

[GrosPied]

Is this quote correct and, if so, what is AC5 substantially equivalent to? "A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA)."

With all we've been discussing regarding the question of whether a 510k application will be approved, I'd be grateful if someone could clarify this. AC5 is unique and for that reason valuable, so I'm confused about what the company proposes the "substantially equivalent" device might be.