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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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Apart from the export certificate, a qualified mask producer should also obtain the mask registration certificated granted by China's National Medical Product Administration (NMPA), Li Lin
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