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Wouldn’t be surprised if they used the 510k loophole.
No fucking way. It’s a PMA device. The rub is that M. it stands for market. As in clinical trials have a lower threshold.
Wouldn’t be surprised if they used the 510k loophole.
No fucking way. It’s a PMA device. The rub is that M. it stands for market. As in clinical trials have a lower threshold.
