Sunday, January 22, 2017 4:58:19 PM
I don't see the PMA route. They have a highly reputable consulting group in Biologics Consulting that agree a 510k is achievable and also have a working relationship with the FDA.
I do like the nut flush..
I completely understand why they have not reached out to a major for distribution for they do not want the technology duplicated.
CriTech finished their analysis and now I would assume its in Biologics hands. To much visual exposure for this to be a scam.
In my humble opinion I see 510k, approval, sold..
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