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510(k) Data Aggregation

    K Number
    K230383
    Device Name
    Savvy Surgical Mask - Level 3
    Manufacturer
    ALG Health LLC
    Date Cleared
    2023-03-06

    (21 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALG Health LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
    Device Description
    Not Found
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