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All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices. 6. Intended Use: Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and ...

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Medical Devices and the COVID-19 (Coronavirus) Pandemic Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks…

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Apr 01, 2019 · Subpart A--General Provisions § 878.1 - Scope. § 878.3 - Effective dates of requirement for premarket approval. § 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).. Subpart B--Diagnostic Devices § 878.1800 - Speculum and accessories.. Subpart C [Reserved] Subpart D--Prosthetic Devices

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