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

    TROJAN (TM-TBD) CONDOM

    K Number: K912901 · Decision Feb 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    398
    Applicant Total
    20
    Review Days
    216

    Basic Information

    Device Name
    TROJAN (TM-TBD) CONDOM
    K Number
    K912901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CARTER PRODUCTS
    Date Received
    July 2, 1991
    Decision Date
    February 3, 1992
    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 CARTER PRODUCTS

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    K901200 TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED
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    K901198 TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED
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