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

    Plastic LOR Syringe

    K Number: K201356 · Decision Feb 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    15
    Review Days
    267

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    Basic Information

    Device Name
    Plastic LOR Syringe
    K Number
    K201356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Caina Medical Co.,Ltd
    Date Received
    May 21, 2020
    Decision Date
    February 12, 2021
    Product Code
    CAZ
    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
    CAZ Anesthesia Conduction Kit

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