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

    45 Micron Polyisoprene Condom

    K Number: K231908 · Decision Oct 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    120

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    Basic Information

    Device Name
    45 Micron Polyisoprene Condom
    K Number
    K231908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suretex Limited
    Date Received
    June 29, 2023
    Decision Date
    October 27, 2023
    Product Code
    MOL
    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
    MOL Condom, Synthetic

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