BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TYMPANOSTOMY TUBES (VARIOUS MODELS

    K Number: K820510 · Decision Mar 19, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    TYMPANOSTOMY TUBES (VARIOUS MODELS
    K Number
    K820510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Abco Dist.
    Date Received
    February 23, 1982
    Decision Date
    March 19, 1982
    Product Code
    ETD
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETD Tube, Tympanostomy

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    Other Clearances by Abco Dist.

    K Number Device Name
    K820332 NEEDLE & BLADE COUNTER