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Re: GetSeriousOK post# 80377

Friday, 07/22/2016 2:38:26 AM

Friday, July 22, 2016 2:38:26 AM

Post# of 352924
Serious, you are absolutely correct. Thus, I stand corrected. So I take it that BIEL has not submitted a 513(g), nor a De Novo? If they have yet to make the aforementioned submittals, then we have at least additional months to wait before the FDA makes its decision.

Wait time for respective submissions:
513(g): within 60 days
De Novo: within 120 days



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