FDA 510(k) Number

Section 510(k) of the Food, Drug and Cosmetic Act requires that all device manufacturers must register to notify the FDA, at least 90 days in advance, of their intent to market any medical device. This is known as a Premarket Notification, and allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories (Class I, II, III). Devices are awarded specific numbers for each product. Major product modifications may require a new 510(k) number. Search FDA releasable 510(k) database at http://www.fda.gov/cdrh/510khome.html