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

    PLAK VAK - PV-10

    K Number: K864540 · Decision Jul 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    225

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    Basic Information

    Device Name
    PLAK VAK - PV-10
    K Number
    K864540
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6510
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Paul S. Barclay, D.D.S. , Ltd.
    Date Received
    November 19, 1986
    Decision Date
    July 2, 1987
    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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