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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.fda 510k en14683 dental face masks size - KN95/N95 Face fda 510k en14683 dental face masks size. Description: Surgical Masks Premarket Notification [510(k We recommend that you provide the following information about your device and any addon features such as a face shield or wraparound visor: size; or dental face mask. 510(k), FDA2 Characteristics of Respirators and Medical Masks , high quality fda 510k clear surgical face masks sizeSuggested Citation:"2 Characteristics of Respirators and Medical Masks."Institute of Medicine. 2006. Reusability of Facemasks During an Influenza Pandemic: Facing the Flu.Washington, DC: The National Academies Press. doi: 10.17226/11637.

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