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Re: purdue pete post# 85005

Wednesday, 09/28/2016 2:22:09 PM

Wednesday, September 28, 2016 2:22:09 PM

Post# of 330577
I hadn't heard of another meeting. Is this confirmed? If so, why would the FDA spend more time with BIEL and their lawyers? To work out the details of a 510(k) I say. If they were denying BIEL, they wouldn't spend the time to physically meet with them---they would simply send them a letter IMHO. Interesting indeed.