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

    One Touch Spiral Condom

    K Number: K210294 · Decision Sep 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    233

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    Basic Information

    Device Name
    One Touch Spiral Condom
    K Number
    K210294
    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
    February 2, 2021
    Decision Date
    September 23, 2021
    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.

    K Number Device Name
    K220273 Onetouch Non-paraben Lubricant Gel
    K210095 Playboy Premium Silicone Lubricant
    K211450 Playboy 3 Contour Condom
    K171213 One Touch Condom with Benzocaine