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FDA 510(k)

R&G Surgical Mask

K-Number: K232112 · 2024-04-02

Decision Date2024-04-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

R&G Surgical Mask is a medical device manufactured by R&G Seguridad E Higiene Industrial S.A.C.. It received FDA 510(k) clearance on 2024-04-02 under approval number K232112. 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 R&G Surgical Mask?

R&G Surgical Mask is a medical device that received FDA 510(k) clearance on 2024-04-02. It is manufactured by R&G Seguridad E Higiene Industrial S.A.C.. The 510(k) number is K232112.

When was R&G Surgical Mask approved by the FDA?

R&G Surgical Mask received FDA 510(k) clearance on 2024-04-02, under approval number K232112.

What company makes R&G Surgical Mask?

R&G Surgical Mask is manufactured by R&G Seguridad E Higiene Industrial S.A.C..

What is the FDA product code for R&G Surgical Mask?

The FDA product code for R&G Surgical Mask is FXX.

Related Devices (Code: FXX)

Official Source

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