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

    MULTI-UNIT, MULTI-PURPOSE DEVICE

    K Number: K813638 · Decision May 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    MULTI-UNIT, MULTI-PURPOSE DEVICE
    K Number
    K813638
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6510
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    The Scott & Fetzer Co.
    Date Received
    December 30, 1981
    Decision Date
    May 7, 1982
    Product Code
    EFS
    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
    EFS Unit, Oral Irrigation

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