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

    DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM

    K Number: K072762 · Decision Jan 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    116

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    Basic Information

    Device Name
    DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
    K Number
    K072762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depalt, Inc.
    Date Received
    September 28, 2007
    Decision Date
    January 22, 2008
    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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