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China Fda Mask, Fda Mask Manufacturers, Suppliers, Price

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Surgical Masks - Premarket Notification [510(k

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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January 24, 2019 Shanghai Sungo Management

Form Approved:OMB No. 0910-0120 Expiration Date:06/30/2020 See PRA Statement below. 510(k) Number (if known) K182514 Device Name Disposable Surgical Face Mask Indications for Use (Describe) The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from

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Surgical Masks - Premarket Notification [510(k

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.