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

    AGA TRACH TIES

    K Number: K922657 · Decision Jul 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    AGA TRACH TIES
    K Number
    K922657
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5770
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aga Medical Products, Inc.
    Date Received
    June 3, 1992
    Decision Date
    July 2, 1992
    Product Code
    CBH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CBH Device, Fixation, Tracheal Tube

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    Other Clearances by Aga Medical Products, Inc.

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