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FDA 510(k)

WELLTRUST WT-III Mask with Flat Earloop

K-Number: K211751 · 2021-09-17

Decision Date2021-09-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WELLTRUST WT-III Mask with Flat Earloop is a medical device manufactured by Lonestar Meadows, LLC. It received FDA 510(k) clearance on 2021-09-17 under approval number K211751. 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 WELLTRUST WT-III Mask with Flat Earloop?

WELLTRUST WT-III Mask with Flat Earloop is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Lonestar Meadows, LLC. The 510(k) number is K211751.

When was WELLTRUST WT-III Mask with Flat Earloop approved by the FDA?

WELLTRUST WT-III Mask with Flat Earloop received FDA 510(k) clearance on 2021-09-17, under approval number K211751.

What company makes WELLTRUST WT-III Mask with Flat Earloop?

WELLTRUST WT-III Mask with Flat Earloop is manufactured by Lonestar Meadows, LLC.

What is the FDA product code for WELLTRUST WT-III Mask with Flat Earloop?

The FDA product code for WELLTRUST WT-III Mask with Flat Earloop is FXX.

Related Devices (Code: FXX)

Official Source

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