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U.S. Department of Health and Human Services

510(K) Premarket Notification

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A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.

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     Advanced Search      510(k) - Decisions
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