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FDA 510(k)

MASC Surgical Mask

K-Number: K211984 · 2021-07-25

Decision Date2021-07-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASC Surgical Mask is a medical device manufactured by Mid-America Safety Corp.. It received FDA 510(k) clearance on 2021-07-25 under approval number K211984. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASC Surgical Mask?

MASC Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-07-25. It is manufactured by Mid-America Safety Corp.. The 510(k) number is K211984.

When was MASC Surgical Mask approved by the FDA?

MASC Surgical Mask received FDA 510(k) clearance on 2021-07-25, under approval number K211984.

What company makes MASC Surgical Mask?

MASC Surgical Mask is manufactured by Mid-America Safety Corp..

What is the FDA product code for MASC Surgical Mask?

The FDA product code for MASC Surgical Mask is FXX.

Related Devices (Code: FXX)

Official Source

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