BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

    K Number: K182268 · Decision Apr 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    3
    Review Days
    227

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    Basic Information

    Device Name
    EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
    K Number
    K182268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flat Medical Co., Ltd.
    Date Received
    August 21, 2018
    Decision Date
    April 5, 2019
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Flat Medical Co., Ltd.

    K Number Device Name
    K212615 EpiFaith CV
    K192421 EpiFaith Syringe