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  • kbentleymsm-edu replied to the topic "510K is Nonsense"3 years, 10 months ago

    Posted by: @christoph To a layman, a surperficial assessment of 510K process is that it is nonsensical.WHY are devices being compared to devices created 40 years ago.This makes no sense to me. Why arent the just assessed on their own…   Read more»