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

    ULS 8-86

    K Number: K863163 · Decision Sep 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    ULS 8-86
    K Number
    K863163
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    American Instrument Manufacturer'S, Inc.
    Date Received
    August 18, 1986
    Decision Date
    September 22, 1986
    Product Code
    DYN
    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
    DYN Mouthpiece, Saliva Ejector

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