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

    EPIDURAL MINIPACK

    K Number: K924541 · Decision Jul 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    23
    Review Days
    304

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    Basic Information

    Device Name
    EPIDURAL MINIPACK
    K Number
    K924541
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5220
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Concord/Portex
    Date Received
    September 8, 1992
    Decision Date
    July 9, 1993
    Product Code
    BYO
    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
    BYO Bottle, Blow

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