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    Apr 24, 2020 · On April 18, 2020, in response to concerns relating to insufficient supply and availability of face masks, 1, 2. the U.S. Food and Drug Administration (FDA) issued an Emergency Use Warning about Face Mask Imports FDAImportsApr 02, 2020 · FXX:Any third-party FDA registration/medical device listing certificate that lists a mask under the Product Code FXX, but the manufacturer does not own a 510(k) for the device as a surgical mask (and thus the mask is not in FDAs 510(k) database), then it is a fraudulent listing, the device is adulterated and misbranded and is subject to

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