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

    STANDARD LATEX CONDOM

    K Number: K884399 · Decision Mar 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    398
    Applicant Total
    10
    Review Days
    133

    Basic Information

    Device Name
    STANDARD LATEX CONDOM
    K Number
    K884399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    SCHMID LABORATORIES, INC.
    Date Received
    October 19, 1988
    Decision Date
    March 1, 1989
    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 SCHMID LABORATORIES, INC.

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    K880202 OKAMOTO CONDOMS
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