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Re: pendragon8062 post# 31156

Wednesday, 11/03/2010 1:30:15 PM

Wednesday, November 03, 2010 1:30:15 PM

Post# of 59550
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