Guidance for the Content of Premarket Notifications for Urine Drainage Bags

Published: 1994-06-07

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

Official Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-notifications-urine-drainage-bags PDF: https://www.fda.gov/media/72716/download

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