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

    SAXON ULTRA THIN

    K Number: K900360 · Decision Apr 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    7
    Review Days
    67

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    Basic Information

    Device Name
    SAXON ULTRA THIN
    K Number
    K900360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Safetex Corp.
    Date Received
    January 25, 1990
    Decision Date
    April 2, 1990
    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 Safetex Corp.

    K Number Device Name
    K922889 CONDOOM SHELF LIFE -- MODIFICATIONS
    K910550 CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
    K902509 SAXON RIBBED CONDOMS
    K900359 EMBRACE
    K900357 GOLD CIRCLE COIN
    K900358 SAXON WET LUBE