Kit Certification for 510(k)s

Published: 1997-06-30

Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Premarket Docket: FDA-2020-D-0957

Official Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/kit-certification-510ks

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