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

    OTOLOGICAL VENTILATION TUBES

    K Number: K802638 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    8
    Review Days
    21

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    Basic Information

    Device Name
    OTOLOGICAL VENTILATION TUBES
    K Number
    K802638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Santa Barbara Medco, Inc.
    Date Received
    October 22, 1980
    Decision Date
    November 12, 1980
    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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    Hummingbird Tympanostomy Tube System

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    Other Clearances by Santa Barbara Medco, Inc.

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    K821187 MEDCO CUSTOM EAR PROTECTOR MOLD KIT
    K812069 BORES* DEPTH GAUGE
    K812071 RK IV SURGICAL BLADES
    K812070 BORES* ADJUSTABLE BLADE HOLDER