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

    SHEER THIN AROMAS BLUE LATEX CONDOM

    K Number: K004016 · Decision Mar 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    SHEER THIN AROMAS BLUE LATEX CONDOM
    K Number
    K004016
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eagle Twe, Inc.
    Date Received
    December 27, 2000
    Decision Date
    March 27, 2001
    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 Eagle Twe, Inc.

    K Number Device Name
    K051273 DIVAS DUAL PLEASURE MALE LATEX CONDOM
    K010028 SHEER THIN AROMAS RED LATEX CONDOM
    K004051 SHEER THIN AROMAS YELLOW LATEX CONDOM
    K004036 SHEER THIN AROMAS GREEN LATEX CONDOM