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DREAMCON, FDA 510(K) cleared!

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Name 최고관리자 작성일13-07-04 11:56 View5,130 Comment0


DREAMCON is FDA510(K) cleared. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

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