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

    EVRON GEL

    K Number: K961222 · Decision Jun 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    EVRON GEL
    K Number
    K961222
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmaceutical Innovations, Inc.
    Date Received
    March 28, 1996
    Decision Date
    June 26, 1996
    Product Code
    KMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    RA
    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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