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

    HYDRO FLOSS

    K Number: K923937 · Decision Feb 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    569

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    Basic Information

    Device Name
    HYDRO FLOSS
    K Number
    K923937
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6510
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hydro Floss, Inc.
    Date Received
    August 5, 1992
    Decision Date
    February 25, 1994
    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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