BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

    K Number: K171518 · Decision Jan 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    5
    Review Days
    226

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    Basic Information

    Device Name
    Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
    K Number
    K171518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Kindly Medical Devices Co., Ltd.
    Date Received
    May 24, 2017
    Decision Date
    January 5, 2018
    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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