Grapefruit USA Inc (GPFT)

[Approved]

Everyone read..the 150 day FDA time limit is not in effect for IMGG. I don't know why you are saying it does and its the end all say all date of Sept 8th or 9th as the 150 day limit. Only 510k apps that have been sent in since the 150 day time limit was in effect are affected! IMGG sent in their re-submission before this new 150 day limit rule! IMGG is not going to be held by the FDA to the new 150 day limit rule. You must realize this, because this date of Sept 9th is going to pass and all it is going to do is lower pps again and lower our positives hopes of approval.

Once again, Imaging3 510k is not on track with the 150 day FDA time limit. Only companies that filed after the new time limit rule.