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

    Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization

    K Number: K220057 · Decision Oct 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    274

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    Basic Information

    Device Name
    Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
    K Number
    K220057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shinva Ande Healthcare Apparatus Co., Ltd.
    Date Received
    January 6, 2022
    Decision Date
    October 7, 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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    K202060 Disposable IV catheter
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