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Service Items > FDA510（K） certification

FDA510（K） certification

510k, in essence, is a "premarket notification" (PMN) that must be done before medical products are marketed in the United States. It is a section of the act of the food, drug and cosmetics (fd&c) action committee of the United States, and the section of this act happens to be in section 510 of the fd&c act of the United States

FDA510K注冊(cè)