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並前往https://www.federalregister.gov/documents/2018/04/12/2018-07564/expansion-of-the-abbreviated-510k-program-demonstrating-substantial-equivalence-through-performance

Expansion of the Abbreviated 510(k) Program - Federal Register

Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and ...

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