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– Once you have submitted your 510(k), the FDA has ninety days time to review it
– Please note that review does not mean clearance
– If your product is cleared, the FDA will point you an email letter, with an assigned 510(k) number, which says they “have determined your device is substantially equivalent to legally marketed predicate devices and you’ll set out to promote your device at the mercy of the typical controls provisions of the Food, Drug and Cosmetics Act
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Read Also – US FDA 510k Consulting Services and Procedures
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