BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇭 Thailand

    One Touch Condom with Benzocaine

    K Number: K171213 · Decision Jan 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    262

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    Basic Information

    Device Name
    One Touch Condom with Benzocaine
    K Number
    K171213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thai Nippon Rubber Industry Public Company Limited.
    Date Received
    April 25, 2017
    Decision Date
    January 12, 2018
    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 Thai Nippon Rubber Industry Public Company Limited.

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