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BenK

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BenK

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Re: held2long post# 45989

Monday, 10/16/2017 5:46:07 PM

Monday, October 16, 2017 5:46:07 PM

Post# of 52074
I'm just guessing on this, but considering the complications that MZEI has encountered with the FDA on this very point - is AS a class l device and doesn't need approval, or not - they may have deemed it prudent to go for the CE Mark in Europe and not wait for some bureaucrat to play games with them.
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