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510(k) Data Aggregation

    K Number
    K100385
    Device Name
    NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
    Manufacturer
    LUV N' CARE, LTD.
    Date Cleared
    2010-03-24

    (36 days)

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

    LUV N' CARE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is indicated to express and collect milk from the breasts of lactating women.
    Device Description
    The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is a BPA-free breast pump designed with an electronic memory that allows the lactating mother to save and control personal pump settings or use one of the two settings that are already pre-programmed. The "soft flex" funnel protects and actuates in and out, replicating baby's suckling action and stimulating a fast, natural let-down. In addition to mains power, this single electronic pump can also operate using battery power or as a manual pump.
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    K Number
    K092494
    Device Name
    GEL FILLED GUM SOOTHER
    Manufacturer
    LUV N' CARE, LTD.
    Date Cleared
    2010-03-01

    (199 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUV N' CARE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
    Device Description
    Teething Ring – Water or Gel Filled
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