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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
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)]

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