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FDA 510(K) Submission | 510K Clearance (Approval) | FDA
FDA 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 that is not subject to premarket approval (PMA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
FDA 510k Consultants for Submission & Approval Process
FDA 510k Consultants. We are FDA 510k Consultants We provide FDA approval, process & guidance. Our experienced consulting team guides you in the right direction about cost, requirements and, clearances. When bringing a medical device to market in the United States, based on the risk class and intended use of the device to determine whether to (a) submit a premarket notification, also known as
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