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510(k) Data Aggregation

    K Number
    K081932
    Device Name
    ENDEARE BREAST PUMP
    Date Cleared
    2009-01-22

    (199 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYGEIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EnDeare™ Breast Pump is indicated to express and collect milk from the breasts of lactating women
    Device Description
    The product is a powered breast pump with accessories that is used to express and collect milk from the breasts of lactating women
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