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DewmBoom

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Re: toomuchwasabi post# 134889

Friday, 05/04/2018 7:18:00 PM

Friday, May 04, 2018 7:18:00 PM

Post# of 330214
That is my expectations. But worst case scenario, BIEL will submit a 510K and the FDA will make a decision with 90 days from receiving the submittal.

Assuming that Biel will submit by May 18, we shall hear back on or before August 18 or so. Although, I truly believe that it’s a waste of time to make it go that long.
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