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

    DUKAL LUBRICATING JELLY

    K Number: K113689 · Decision May 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    7
    Review Days
    141

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    Basic Information

    Device Name
    DUKAL LUBRICATING JELLY
    K Number
    K113689
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dukal Corporation
    Date Received
    December 15, 2011
    Decision Date
    May 4, 2012
    Product Code
    KMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KMJ Lubricant, Patient

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