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Business · 05/03/2004Updated: 10/17/2026 · 1 min read

FDA Releases Guidance for Surgical Masks Premarket Notification Submissions

Summary

The Food and Drug Administration (FDA) has released a guidance document to help the industry prepare premarket notification submissions for surgical masks, as required by the 510(k) process.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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