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Re: Chemic76spirit post# 42120

Friday, 05/06/2011 8:06:10 AM

Friday, May 06, 2011 8:06:10 AM

Post# of 59549
"a video demonstration that will not negatively impact our 510(k) submission or create any issues with the FDA in general."

So, just as we have said many times before, the FDA has rules limiting what can be shown in a demo to the public for a device going through 510(k) submission. I would have been surprised if he was allowed to demo it to the general public.




Keeping it real.
Homer