BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GUM MASSAGER

    K Number: K911418 · Decision Jul 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    125
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    107

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    Basic Information

    Device Name
    GUM MASSAGER
    K Number
    K911418
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6650
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Burn-Henderson Partnership
    Date Received
    April 1, 1991
    Decision Date
    July 17, 1991
    Product Code
    JET
    Advisory Committee
    Dental
    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
    JET Pick, Massaging

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