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510(k) Data Aggregation

    K Number
    K082802
    Device Name
    MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
    Manufacturer
    LEARNING CURVE BRANDS INC. THE FIRST YEARS
    Date Cleared
    2008-10-09

    (15 days)

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

    LEARNING CURVE BRANDS INC. THE FIRST YEARS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powered Breast Pump to express milk from the breast.
    Device Description
    The miPump Electric / Battery Breast Pump is a quiet, small, safe and effective system to express milk from the breast. It has electrical pressure control pumping system to generate suction. This device is designed with eight suction levels, which are selectable by the user via pressing the suction button. It is powered either by four (4) AA batteries (not included with package) or powered electrically by utilizing the AC adaptor (6V) which is provided in the package and can be plugged into any standard wall outlet.
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