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Surgical Masks - Premarket Notification [510(k ... - fda.gov. This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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FDA Medical Device Listing. Wellmien Surgical Masks meet EN14683 standard of EU, and also have acquired FDA 510(K). With superior products and services, our company has won the trust and support from new and old customers. Pursuit of 'New Products, Better Quality with Better Services' is our shared goal for all Wellmien staff to thrive.

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