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510(k) Data Aggregation

    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
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powered Breast Pump to express milk from the breast.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a breast pump. It does not contain information about acceptance criteria or a study proving device performance as requested. The content focuses on the regulatory clearance for the device, including its classification and compliance requirements. Therefore, I cannot provide the requested information based on this document.

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