Premarket notification

Premarket notification or 510(k) is a process by which a submitter notifies the FDA at least 90 days prior to the submitters inroduction of any appropriate device (some Class I and most Class II devices) into interstate commerce. The submission must include a product classification based on safety and effectiveness. Based on the information and the date submitted, the FDA determines whether the product is substantially equivalent to a legally marketed predicate device. When the FDA makes that finding, the submitter is notified and may market the device. These submissions are called 510(k)s because the report submission requirement is identifies in the Act under this section number

See: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm