BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

    K Number: K082307 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
    K Number
    K082307
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Evenflo Company, Inc.
    Date Received
    August 13, 2008
    Decision Date
    September 11, 2008
    Product Code
    HGX
    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
    HGX Pump, Breast, Powered

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    Other Clearances by Evenflo Company, Inc.

    K Number Device Name
    K102600 SIMPLYGO BREAST PUMP
    K100435 AMEDA PLATINUM BREAST PUMP
    K092770 SIMPLYGO HANDS FREE BREAST PUMP
    K053493 BERRY FRUITY TEETHER
    K052909 EVENFLO ELAN BREAST PUMP
    K022933 EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
    K013226 EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT