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Tz3sports

05/31/22 1:00 PM

#30839 RE: MouthBreather #30838

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.