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510(k) Data Aggregation

    K Number
    K022140
    Device Name
    WHISPER WEAR BREAST PUMP
    Manufacturer
    WHISPER WEAR
    Date Cleared
    2002-09-30

    (90 days)

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

    WHISPER WEAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.
    Device Description
    The Whisper Wear Breast Pump is a self-contained, battery-operated device that is worn under and held in place by everyday clothing. A DC motor imparts motion to a silicone diaphragm that develops a negative pressure that expresses milk from the breast to a collection bag.
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