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Re: MouthBreather post# 30838

Tuesday, 05/31/2022 1:00:22 PM

Tuesday, May 31, 2022 1:00:22 PM

Post# of 31325
Not sure what you just said… this specific 510k application is at the end point.

A 510k application from start to finish does not take longer then a year and that’s with an extension granted.

If a device were to be denied and entirely new 510k application would need to be submitted.

It’s not complex.
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