Replies to post #5918 on Grapefruit USA Inc (GPFT)

[mr_sano]

Gold,

Whats your take on whether Dominon is substantially equivalent to current devices. If the 510K process is meant for expediting devices to market but is truley novel then shoulnt they have filed a PMA?

[Frank39]

Thanks for any attempt to clarify. I'm not concerned. I was just trying to answer the question posed by "BornTwice" I agree no one should be concerned about the labeling issue.

[ndforlife]

GC - I had a discuss with Dean over this very thing. The restrictions are not with the device but what areas can use it. For example it can be used in trauma but not at my brothers hog farm.. :-) Just an example..

The areas that this can be used will have full functionality..