BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT

    K Number: K013226 · Decision Dec 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    84

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    Basic Information

    Device Name
    EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
    K Number
    K013226
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Evenflo Company, Inc.
    Date Received
    September 27, 2001
    Decision Date
    December 20, 2001
    Product Code
    HGY
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HGY Pump, Breast, Non-Powered

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