Just curious Johny - what is your 10 day suggestion for possible FDA 510(K) decision based on please.....the BIEL PR stated the next meeting scheduled with FDA is the 20th, 12 days from now, at which time I believe the PR also said BIEL would have its answers to the latest FDA questions prepared for submission - wouldn't FDA require time to consider those answers and then the parties consider steps, timelines and any required changes to Special Controls, label and insert details moving forward from there?
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