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Gramps

09/28/16 2:22 PM

#85006 RE: purdue pete #85005

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.

sleepeasy6969

09/28/16 2:48 PM

#85021 RE: purdue pete #85005

Where did you see that? I didn't see anything like that in the update.

DDGUY

09/28/16 3:00 PM

#85023 RE: purdue pete #85005

What fda meeting ?