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Re: macnqueso post# 13606

Friday, 07/11/2014 9:14:51 PM

Friday, July 11, 2014 9:14:51 PM

Post# of 54998
Again this is just some peripheral stuff to keep the price from collapsing with the delay of the bell ringing. Get real folks....this process and the ultimate 911(g) approval will take years even in the best case scenario....while this is not PDUFA or a 510K it will be extremely lengthy ... There are 100 of pages of guidance in this area on the FDA website for modifed risk..
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