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

    THE KLINE APPLICATOR

    K Number: K823517 · Decision Jan 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    THE KLINE APPLICATOR
    K Number
    K823517
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Kline Technologies, Ltd.
    Date Received
    November 29, 1982
    Decision Date
    January 18, 1983
    Product Code
    HGD
    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
    HGD Applicator, Vaginal