BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    K-GEL

    K Number: K872128 · Decision Jun 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    10

    Basic Information

    Device Name
    K-GEL
    K Number
    K872128
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    TARO PHARMACEUTICALS, INC.
    Date Received
    June 2, 1987
    Decision Date
    June 12, 1987
    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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