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

    SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM

    K Number: K904380 · Decision Apr 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    925

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    Basic Information

    Device Name
    SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM
    K Number
    K904380
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Custom Medical Concepts, Inc.
    Date Received
    September 26, 1990
    Decision Date
    April 8, 1993
    Product Code
    MIA
    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
    MIA Needle, Spinal, Short Term

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