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

    CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE

    K Number: K983878 · Decision Jan 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
    K Number
    K983878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E. Benson Hood Laboratories, Inc.
    Date Received
    November 2, 1998
    Decision Date
    January 29, 1999
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by E. Benson Hood Laboratories, Inc.

    K Number Device Name
    K841350 SALIVARY BYPASS TUBE
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    K841266 MONTGOMERY TRACHEAL T-TUBE
    K841347 LARYNGEAL STENT
    K841348 UMBRELLA KEEL