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

    49-610 NIKO-NOSE FIXATION TAPE

    K Number: K902896 · Decision Oct 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    46
    Applicant Total
    15
    Review Days
    112

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    Basic Information

    Device Name
    49-610 NIKO-NOSE FIXATION TAPE
    K Number
    K902896
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5770
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Nikomed U.S.A., Inc.
    Date Received
    July 3, 1990
    Decision Date
    October 23, 1990
    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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