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

    OFNat Lubricant (L15)

    K Number: K221243 · Decision Sep 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    6
    Review Days
    151

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    Basic Information

    Device Name
    OFNat Lubricant (L15)
    K Number
    K221243
    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
    May 2, 2022
    Decision Date
    September 30, 2022
    Product Code
    NUC
    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
    NUC Lubricant, Personal

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