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<p>[QUOTE="anonymous, post: 6098166"]Thanks for the lesson fukstick. That some pretty 101 level stuff. </p><p><br /></p><p>Unfortunately you are incomplete in understanding the 510k as a track for both new and "equivalent" products. </p><p><br /></p><p>It is still an FDA clearance to market. You can slander and call them "aftermarket" all you want but they are deemed functionally equivalent. I don't see a pile of lawsuits I've people plugging conmed or megadyne pads and pencils into valleylab boxes. (Maybe with the FT10 though and the flamethrower anomaly.)</p><p><br /></p><p>There is not a product in the MITG bag that is not a 510k clearance.[/QUOTE]</p><p><br /></p>
[QUOTE="anonymous, post: 6098166"]Thanks for the lesson fukstick. That some pretty 101 level stuff. Unfortunately you are incomplete in understanding the 510k as a track for both new and "equivalent" products. It is still an FDA clearance to market. You can slander and call them "aftermarket" all you want but they are deemed functionally equivalent. I don't see a pile of lawsuits I've people plugging conmed or megadyne pads and pencils into valleylab boxes. (Maybe with the FT10 though and the flamethrower anomaly.) There is not a product in the MITG bag that is not a 510k clearance.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Covidien
>
AEON Stapler
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Covidien
>
AEON Stapler
>