Grapefruit USA Inc (GPFT)

[mr_sano]

Dean is the professional here.If he knows its not the same as the predicate then why spend millions of dollars in time money trying to force a round peg through a square hole. After all he has done 3-4 510K before right? SO lets say for argument sake that DVIS is better than the predicate but Deans special controls are new and maynot provide the level of comfort the FDA is looking for. DEan will need to prove his control systems. Thats not insurmountable but thats will require engineering and lots of legal wrangling.