BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    ACCU-BITE HOME KIT DISCLUDER

    K Number: K980953 · Decision Oct 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    208

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    Basic Information

    Device Name
    ACCU-BITE HOME KIT DISCLUDER
    K Number
    K980953
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jerome M. Simon
    Date Received
    March 13, 1998
    Decision Date
    October 7, 1998
    Product Code
    MQC
    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
    MQC Mouthguard, Prescription

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