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

    MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.

    K Number: K904273 · Decision Oct 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    20
    Review Days
    44

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    Basic Information

    Device Name
    MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
    K Number
    K904273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Carter Products
    Date Received
    September 17, 1990
    Decision Date
    October 31, 1990
    Product Code
    LTZ
    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
    LTZ Condom With Nonoxynol-9

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LTZ), ordered by most recent decision date.

    CAUTION CONDOMS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DOUBLE SPRINGERS NONOXNOL 9 CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Carter Products

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    K904782 ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
    K901202 TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
    K901201 TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED
    K901198 TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED
    K901193 TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)
    K901197 TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL
    K901194 TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL
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