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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K950750,K973501,K983776
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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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