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

    FAST TRACT TRANSTRACHEAL PROCEDURE KIT

    K Number: K970018 · Decision Mar 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    223
    Registration Numbers
    223
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    FAST TRACT TRANSTRACHEAL PROCEDURE KIT
    K Number
    K970018
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    L.W. Ward and Assoc., Inc.
    Date Received
    January 2, 1997
    Decision Date
    March 28, 1997
    Product Code
    LRC
    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
    LRC Instrument, Ent Manual Surgical

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