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Our website uses cookies and similar technologies to personalize the advertising shown to you and to help you get the best experience on our website. For more information, see our Privacy & Cookie Policy

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510(k) Premarket Notification

510(k) Premarket Notification

The surgical face mask is listed in the Premarket Notification(510k) by US FDA. A 510(k) is a premarket submission made to FDA to demonstrate that the product to be marketed is as safe and effective.

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