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510(k) Data Aggregation
K Number
K211751Device Name
WELLTRUST WT-III Mask with Flat Earloop
Manufacturer
Date Cleared
2021-09-17
(102 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Lonestar Meadows LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WELLTRUST™ WT-III Mask with Flat Earloop are indicated as a protective nose and mouth covering for patients and healthcare personnel. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid and particulate material. These surgical masks are single use, disposable devices provided non-sterile.
Device Description
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