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FDA 510(k)

WELLTRUST WT-III Mask with Flat Earloop

Número K: K211751 · 2021-09-17

RequerenteLonestar Meadows, LLC
Data da decisão2021-09-17
Código do produtoFXX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

WELLTRUST WT-III Mask with Flat Earloop is the device name listed in this FDA 510(k) record. The listed applicant is Lonestar Meadows, LLC. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K211751. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Lonestar Meadows, LLC. The 510(k) number is K211751.

When did WELLTRUST WT-III Mask with Flat Earloop receive FDA 510(k) clearance?

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

Who is the listed applicant for WELLTRUST WT-III Mask with Flat Earloop?

The FDA 510(k) record lists Lonestar Meadows, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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