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Guidance Documents/Guidance-Document/Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 2, 2000

March 18, 2020

Center for Devices and Radiological Health

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