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Karensitas
@karensitas
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Joined: Jul 15, 2025
Last seen: Jul 23, 2025
Topics: 0 / Replies: 1
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RE: Discussion Topic: The de Novo 510(k) Process

The De Novo route is a solid option when there’s no clear device to compare to. Skipping the 510(k) step makes things faster, which is a big help for ...

2 weeks ago