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MouthBreather

05/31/22 12:30 PM

#30838 RE: Tz3sports #30835

exactly what i said, it can take longer than a year to have a device PMA, takes years of research and trials to get to that submission point, then they can come back with amendments etc, just because you think the 510k submission process starts over, it doesnt, its still all apart of the same device, so maybe you are confused