Premarket Notification 510(k) | FDA
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
WEBOct 3, 2022 · 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 …
DA: 55 PA: 85 MOZ Rank: 36