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

    A.C.I. TRACH TIE

    K Number: K882891 · Decision Sep 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    A.C.I. TRACH TIE
    K Number
    K882891
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5770
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Auxiliary Care, Inc.
    Date Received
    July 11, 1988
    Decision Date
    September 19, 1988
    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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