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As an alternative to submitting an Abbreviated 510(k), you may submit a Traditional 510(k) that provides all of the information and data required under 21 CFR 807.87.

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(Mask, Surgical) - FDA 510(k) Applications Database

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Ear-loops are made of soft elastic Ear-loops are made of soft loops, elastic loops. The nose piece is malleable aluminum The nose piece is malleable wire aluminum wire Dimensions Large l8x9crn, Medium:NA Dimensions 17.5 x9.5cm, Small 14.5x9 cmNA Mask style Flat Pleated Flat Pleated Design Ear Loop Ear Loop

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510(k) Premarket Notification - accessdata.fda.gov

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