A Premarket Notification [510(k)] is a premarket submission made to FDA to demonstrate the device being 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).The submitter may market the device immediately after 510(k) clearance is granted. Three types of Premarket Notification 510(k) submissions for marketing application: Traditional, Special, and Abbreviated.
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