BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40

    K Number: K863707 · Decision Sep 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    3

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    Basic Information

    Device Name
    LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40
    K Number
    K863707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Manexim Multicorp, Ltd.
    Date Received
    September 23, 1986
    Decision Date
    September 26, 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 Manexim Multicorp, Ltd.

    K Number Device Name
    K863706 LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50
    K851292 LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20
    K851291 LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30
    K851290 LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10