BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    FITme Customized Silicone Implant

    K Number: K232593 · Decision Nov 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    FITme Customized Silicone Implant
    K Number
    K232593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keosan Trading Co.
    Date Received
    August 25, 2023
    Decision Date
    November 22, 2023
    Product Code
    FWP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FWP Prosthesis, Chin, Internal

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    Other Clearances by Keosan Trading Co.

    K Number Device Name
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