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

    ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS

    K Number: K971132 · Decision Sep 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    160

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    Basic Information

    Device Name
    ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
    K Number
    K971132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G. Premjee (Usa), Inc.
    Date Received
    March 27, 1997
    Decision Date
    September 3, 1997
    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 G. Premjee (Usa), Inc.

    K Number Device Name
    K972836 ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS