The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

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Technology Premarket approval Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Good manufacturing practice Title 21 of the Code of Federal Regulations Investigational Device Exemption Title 21 CFR Part 11 Food and Drug Administration Medicine Health		The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 843,90 KB Share Document on Facebook

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