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

    Sterile Safety Hypodermic Needles for Single Use

    K Number: K213535 · Decision May 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    4
    Review Days
    189

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    Basic Information

    Device Name
    Sterile Safety Hypodermic Needles for Single Use
    K Number
    K213535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Kangkang Medical-Devices Co., Ltd.
    Date Received
    November 5, 2021
    Decision Date
    May 13, 2022
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Zhejiang Kangkang Medical-Devices Co., Ltd.

    K Number Device Name
    K210229 Sterile Auto-Disable Syringes with/without Needle for Single Use
    K210232 Sterile Hypodermic Needles for Single Use
    K210227 Sterile syringe for single use with/without needle