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

    OSSEOTITE IRRIGATION UNIT

    K Number: K901600 · Decision Jun 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    46
    Applicant Total
    9
    Review Days
    76

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    Basic Information

    Device Name
    OSSEOTITE IRRIGATION UNIT
    K Number
    K901600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6510
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Collagen Corp.
    Date Received
    April 6, 1990
    Decision Date
    June 21, 1990
    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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