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# System prepended metadata

title: FDA 510k

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# FDA 510k

In order to demonstrate that a device is at least as safe and effective as the one it replaces, I3CGLOBAL provides a US FDA 510k or 510k Certification for Medical Device file. Visit a website to learn more about this topic.

[FDA 510k](https://www.i3cglobal.com/fda-510k/
)
