If the manufacturer can successfully demonstrate that the device under review is at least as safe and effective as the predicate device of choice, the US FDA will grant the medical device a 510(k) clearance at the conclusion of the premarket or 510(k) submission review. Please get in touch with us or visit our website for more information about 510k consultants. www.reghelps.com/us-fda/510k-premarket-notification/
