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

    Holycon Synthetic Absorbable Sutures

    K Number: K173043 · Decision Dec 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    1
    Review Days
    77

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    Basic Information

    Device Name
    Holycon Synthetic Absorbable Sutures
    K Number
    K173043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nantong Holycon Medical Devices Co., Ltd.
    Date Received
    September 28, 2017
    Decision Date
    December 14, 2017
    Product Code
    GAM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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