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510(k) Data Aggregation

    K Number
    K032845
    Device Name
    EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
    Manufacturer
    THE FIRST YEARS, INC.
    Date Cleared
    2004-04-05

    (207 days)

    Product Code
    HGY
    Regulation Number
    884.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE FIRST YEARS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-powered Breast Pump to express milk from the breast.
    Device Description
    Easy Comfort ™ Deluxe Manual Breast Pump
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    K Number
    K033131
    Device Name
    NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
    Manufacturer
    THE FIRST YEARS, INC.
    Date Cleared
    2003-10-30

    (30 days)

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

    THE FIRST YEARS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powered Breast Pump to express milk from the breast.
    Device Description
    Not Found
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    K Number
    K032566
    Device Name
    NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
    Manufacturer
    THE FIRST YEARS, INC.
    Date Cleared
    2003-09-15

    (25 days)

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

    THE FIRST YEARS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powered Breast Pump to express milk from the breast.
    Device Description
    Natural Comfort ™ Battery / Electric Breast Pump
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    K Number
    K964403
    Device Name
    SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
    Manufacturer
    THE FIRST YEARS, INC.
    Date Cleared
    1997-01-13

    (70 days)

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

    THE FIRST YEARS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powered Simplicity Breast Pump is designed to express milk from the breast.
    Device Description
    The Simplicity Breast Pump uses a mechanical pumping system to generate suction. It is powered either by two (2) standard C batteries (not included with kit) or powered electrically by utilizing the AC adapter which is provided in the kit and can be plugged into any standard wall outlet. The powered motor activates movement of a rubber dlaphragm inside a pumping chamber which provides suction to express breast milk.
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