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Re: RVC post# 87257

Tuesday, 10/25/2016 9:50:22 AM

Tuesday, October 25, 2016 9:50:22 AM

Post# of 330221
Yeah, that's why BIEL and the FDA's top brass have been meeting several times---to go over their disagreements----uh, yeah. I'm going to go with their meeting with FDA as negotiations on getting every piece needed to get this 510(k) approved. I'm going to go with the fact that the FDA has been cordial in those meetings and asking for one last piece of information they need for that approval. That's what I took from the information posted so far.