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(Mask, Surgical) FDA 510(k) Applications Database
FDA 510(k) NumberApplicantDevice NameDecision DateK9101823M COMPANY3M BRAND EAR LOOP FACE MASK, 2000F03/04/1991K9553823M COMPANY3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
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510(k) Premarket Notification
A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR § 807.92 (a) (3) ) that is not subject to premarket approval.
Mask exportThe EU can obtain CE.FDA certification in as
Certified mask products The outbreak of new pneumonia has continued to spread, and the demand for protective masks and other protective equipment has surged overseas. As a major mask manufacturing country, Chinas mask production capacity and export situation have attracted much market attention. A reporter from the Finance Association learned that the business of 
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Warning about Face Mask Imports Benjamin L. England
FXXAny 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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FDAImports Blog » Warning about Face Mask Imports
FIRST (KN95)FDA did NOT blanket authorize KN95s for use in place of N95s or FDA 510(k) cleared masks for surgical use. So, do not purchase or sell a KN95 as a surgical anything. Please think of the heroes in the OR before you think about your balance sheet or your income statement (let that sink in lives before money).