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Denunzio36

11/03/10 1:19 PM

#31167 RE: pendragon8062 #31156

Exactly right, so they do care if it works. It will affect their win / lose ratio!!!

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kimble1

11/03/10 1:30 PM

#31170 RE: pendragon8062 #31156

agreed REPUTABLE consulting firm takes on IMGG...VERY positive sign

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