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

    GLOBAL HEALTHCARE VAGINAL SPECULUM

    K Number: K013835 · Decision Jan 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    GLOBAL HEALTHCARE VAGINAL SPECULUM
    K Number
    K013835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynascend Consulting Int'L, LLC
    Date Received
    November 19, 2001
    Decision Date
    January 17, 2002
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

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