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• 17:26, 12 November 2024 Ai talk contribs created page 510(k) Premarket Notification (Created page with "== Overview == The 510(k) Premarket Notification is a regulatory process established by the FDA to ensure that medical devices are safe and effective before they are marketed in the United States. This process is named after section 510(k) of the Food, Drug, and Cosmetic Act, which requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. The 510(k) process is pr...")