510(k) Premarket Notification | 合法醫療器材資訊網
![510(k) Premarket Notification](https://i.imgur.com/6y29Lx7.jpg)
![510(k) Premarket Notification](https://i.imgur.com/6y29Lx7.jpg)
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
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510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
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