Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities

Published: 1995-09-18

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/addendum-guidance-premarket-notification-510k-submissions-sterilizers-intended-use-health-care

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