Replies to post #30937 on Grapefruit USA Inc (GPFT)

[auh2o]

Benny is right. De novo route is a good possibility at this point. The catch is that Dean needs to get his submission right. 510(k)s aren't rocket science. FDA gives you a template and you fill it in. If you fail because of format errors its because you left sections out or didn't fully answer them.

[ysung]

I have been reading posts bg you and all others
you mentioned but in the end, we got
rejected with all that logic and D.D

to be real, even if imgg appeals, you can't
be serious turning a decision made already
by federal govt.


that is like getting a star out of the sky