Grapefruit USA Inc (GPFT)

[alexdhcfx]

FDA would run it though the 510k process before it ever kicked an application back for reapplying. Unless it was totally messed up or did fit the expected form of the 510k application. if it looks good and it if it is good is something completely different.

All I can say id look at the chart, then follow the flow, there many terminations spots. Not to kill it, but to have it kicked back out for re application. Its not getting denied, persay, it just the FDA saying "wrong place, try this place"

FDA are not so helpful for them to just look at 510k and say "umm...this is never going to pass the test". Wow, I wish it was that simple. But why not? Because the determination process is what says if it is in the right place or not, to do anything else would be impossible or ad hoc behavior