K

To receive a 510(k), a company must provide the FDA with descriptive, and sometimes performance, data to show that their device is "substantially equivalent'' to another device already approved for the market. The company must compare their 510(k) device to one or more similar devices on the U.S. market and provide sufficient evidence to support their substantial equivalency claims. The legally marketed device/s to which equivalence is claimed is called the "predicate" device/s. [1. http:// www.fda.gov/cdrh/devadvice/314.html (accessed October 2005).]

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