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What is FDA 510(k) Clearances?
Section 510(k) of the Food, Drug and Cosmetic Act
Requires device manufacturers who must register
Notify FDA of their intent to market a medical device at least 90 days in advance
his is known as Premarket Notification - also called PMN or 510(k)
US FDA needs all formatlities to be completed
Post detailed review 510(k) clearance is provided by FDA/li>
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