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

    Sterile Syringe with Fixed Safety Needle for Single Use

    K Number: K212652 · Decision Mar 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    191

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    Basic Information

    Device Name
    Sterile Syringe with Fixed Safety Needle for Single Use
    K Number
    K212652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gemtier Medical (Shanghai), Inc.
    Date Received
    August 23, 2021
    Decision Date
    March 2, 2022
    Product Code
    MEG
    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
    MEG Syringe, Antistick

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    Other Clearances by Gemtier Medical (Shanghai), Inc.

    K Number Device Name
    K202493 Medical Face Mask
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    K192679 Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
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