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fda 510k en14683 bird flu face masks size - KN95/N95 Face … fda 510k en14683 bird flu face masks size Description China Disposable FDA 510k Bird Flu Fabric Face Masks disposable FDA 510k bird flu fabric face masksStructure3 plySBPP+MB+SBPP with face visor or without with soft foam or withoutStyleearloopNose clipsingle nose wire double nose wire plastic nose clip aluminum nose clipSizeAdult17.5*9.5cm Child

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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 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. Learn

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