![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, November 03, 2010 1:30:15 PM
here are some
http://www.fda510k.com/
http://www.mdiconsultants.com/
http://abrimed.com/fda-iso-consultants/510k-medical-device-notification.html
there are of course other
Call any of these guys and ask them what they thought the chances are of a ONE MAN SHOW company taking RADIATION emitting device through 510k are
i bet they would have said slim and none and the CEO must be an egomaniac to think he could do it alone
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