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    K Number
    K093648
    Device Name
    SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
    Manufacturer
    SIMPLISSE INC.
    Date Cleared
    2010-07-14

    (231 days)

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

    SIMPLISSE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A personal use electric powered device used to express milk from the breast of lactating women. The device is not intended for hospital use
    Device Description
    The Simplisse Electric Breastfeeding Companion is a personal use electric powered device used to express milk from the breast of lactating women.
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