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

    EPIDURAL ANESTHESIA NEEDLES

    K Number: K854816 · Decision Dec 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    151
    Applicant Total
    2
    Review Days
    16

    Basic Information

    Device Name
    EPIDURAL ANESTHESIA NEEDLES
    K Number
    K854816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    REGANES, INC.
    Date Received
    December 3, 1985
    Decision Date
    December 19, 1985
    Product Code
    BSP
    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
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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    Other Clearances by REGANES, INC.

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