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Re: askjsell post# 64975

Wednesday, 12/02/2015 4:49:44 PM

Wednesday, December 02, 2015 4:49:44 PM

Post# of 333080
That is not proof! As a retired federal employee, I can say that this is a Guideline policy that the FDA follows which depends on when BIEL's 510K review was started by FDA. Just because the 510K was submitted on 8/6/2015 doesn't mean it was placed on FDA schedule for review.


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