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

    TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING

    K Number: K901196 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    398
    Applicant Total
    20
    Review Days
    35

    Basic Information

    Device Name
    TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING
    K Number
    K901196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    CARTER PRODUCTS
    Date Received
    March 12, 1990
    Decision Date
    April 16, 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 CARTER PRODUCTS

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    K904273 MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
    K901202 TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
    K901200 TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED
    K901195 TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED
    K901198 TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED
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