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

    PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME

    K Number: K864570 · Decision Dec 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    40

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    Basic Information

    Device Name
    PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME
    K Number
    K864570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Dongkuk Techco Rubber Industries
    Date Received
    November 20, 1986
    Decision Date
    December 30, 1986
    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 Dongkuk Techco Rubber Industries

    K Number Device Name
    K002060 NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL