Replies to post #32854 on Grapefruit USA Inc (GPFT)

[demus]

We seem to have an experienced team that is well aware of what can and can not be done with the resubmittal of the 510--I choose to pay more attention to their lead and the path that they have mapped out for this process than to pay any attention to you're continued negativism. GLTA

[BennyJ]

Do me a favour. Go to fda site for 510k search, if you choose radiology and clinical trial - yes, you will not find any SE determination. in other words, in the past all the radiology devicess which don't require clinical trials for 510k submission. That is obvious and black and white. Please post with facts.

- class II devices which require clinical trials are Gatronology, neuelogy, some of opthalmic, etc.

Not a single device in Radiology departments. Read and learn.

[Denunzio36]

Provide the link, please

[wiseoldowl]

I think a major law firm that deals with FDA submissions knows a little more than you. I have been telling everyone all along that a new 510K would be submitted. It will be submitted with all improvements that have taken place in the past three years. Great News!!!!!!!!!