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

    SUMMER'S EVE LUBRICATING JELLY

    K Number: K990597 · Decision Jul 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    SUMMER'S EVE LUBRICATING JELLY
    K Number
    K990597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    C.B. Fleet Co., Inc.
    Date Received
    February 24, 1999
    Decision Date
    July 19, 1999
    Product Code
    HIS
    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
    HIS Condom

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    Other Clearances by C.B. Fleet Co., Inc.

    K Number Device Name
    K812728 FLEET DETECTATEST