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Re: likeahawk post# 52965

Monday, 08/01/2016 12:57:25 PM

Monday, August 01, 2016 12:57:25 PM

Post# of 59551
they keep saying they are going to re submit as 510k

FDA at least 3 times has rejected that route and said they need to go the PMA route.

PMA is multiple times more expensive and require clinical trials, none of which IGNG can afford While still in bankruptcy and in default on their bankruptcy payments

It is a ruse to raise funds, They can find somebody, anybody to "submit" something to the FDA, but it is not a PMA and the FDA has repeatedly said this device cannot be submittted as a 510k.

Read the SEC charges against Dean. That's one of the things they emphasized.


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