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FDA 510(k)

WELLTRUST WT-III Mask with Flat Earloop

K-Number: K211751 · 2021-09-17

ApplicantLonestar Meadows, LLC
Decision Date2021-09-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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