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

    Goyo Mouthpiece S

    K Number: K232238 · Decision Apr 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    Goyo Mouthpiece S
    K Number
    K232238
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dimedikorea
    Date Received
    July 28, 2023
    Decision Date
    April 17, 2024
    Product Code
    OBR
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBR Mouthguard, Over-The-Counter

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