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

    DYNAREX STERILE LUBRICATING JELLY

    K Number: K092488 · Decision Dec 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    8
    Review Days
    127

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    Basic Information

    Device Name
    DYNAREX STERILE LUBRICATING JELLY
    K Number
    K092488
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynarex Corporation
    Date Received
    August 13, 2009
    Decision Date
    December 18, 2009
    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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