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

    TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR

    K Number: K964599 · Decision Feb 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
    K Number
    K964599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Line One Laboratories
    Date Received
    November 18, 1996
    Decision Date
    February 14, 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 Line One Laboratories

    K Number Device Name
    K991892 TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
    K970633 TUSTEX FLAVORED CONDOMS
    K964598 TRUSTEX COLA FLAVORD CONDOM
    K964591 TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR