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LisaMadison
LisaMadison  created a new article
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What Are the Steps of the 510(k)-submission Process? | #510(k)-submission Process

What Are the Steps of the 510(k)-submission Process?
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What Are the Steps of the 510(k)-submission Process?

The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market.
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